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Supply Agreement

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 This Supply Agreement involves

MICROMET, INC.

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Title: DEVELOPMENT AND SUPPLY AGREEMENT
Date: 7/20/2010
Industry: Biotechnology and Drugs     Sector: Healthcare

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***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

 

DEVELOPMENT AND SUPPLY AGREEMENT

 

between

 

LONZA SALES AG

 

and

 

MICROMET AG

 

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

 


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

 

Table of Contents

 

1.

Definitions and Interpretation

3

2.

Provision of the Works and Services

9

3.

Micromet's Obligations

12

4.

Governance

13

5.

Inspections; Person in Plant

15

6.

Delivery, Transportation of Product and Testing

16

7.

Price and Terms of Payment

17

8.

Intellectual Property

18

9.

Warranties and Indemnification

20

10.

Confidentiality

24

11.

Option for Commercial Supply Agreement

26

12.

Termination of the Agreement, Termination of Certain Works and Services or Slots

26

13.

Non-Compete

28

14.

Technology Transfer and License

28

15.

Force Majeure

29

16.

Governing Law, Jurisdiction and Enforceability

29

17.

Notices

30

18.

Illegality

31

19.

Quality Agreement

31

20.

Miscellaneous

32

 

 

 

List of Schedules:

32

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

2


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

 

THIS DEVELOPMENT AND SUPPLY AGREEMENT is made the 23 rd day of November 2009 (the " Effective Date ")

 

BETWEEN

 

1.

LONZA SALES AG, of Muenchensteinerstrasse 38, CH-4002 Basel, Switzerland (herein after referred to as " Lonza ") and

 

2.

MICROMET AG, of Staffelseestrasse 2, D-81477 Munich, Germany (herein after referred to as " Micromet ").

 

WHEREAS

 

A.

Micromet is the proprietor of the single-chain bispecific anti-CD19 antibody (CD19 BiTE ® ) known as Blinatumomab or MT103 and controls a manufacturing process and a cell line for manufacture of MT103; and

 

B.

Lonza has the expertise in the evaluation and production of monoclonal antibodies for therapeutic use using different processes and cell lines in accordance with international regulatory requirements; and

 

C.

Micromet and Lonza have previously entered into a Services Agreement dated September 28, 2009 regarding the performance of a  [***]  to  [***]  for the manufacturing of Micromet’s MT103 by Lonza; and

 

D.

Micromet wishes to contract Lonza for services relating to the development of the Process (as defined herein) including all documentation, in each case, suitable to obtain regulatory approval for commercialization of MT103 as a therapeutic product and the manufacture of MT103 as described in this Agreement, and

 

E.

Lonza is prepared to perform such services for Micromet on the terms and conditions set out herein.

 

NOW IT IS AGREED AS FOLLOWS:

 

1.

Definitions and Interpretation

 

The following terms shall have the following meanings unless the context requires otherwise:

 

" Affiliate "

 

means any company, partnership or other entity which directly or indirectly Controls, is Controlled by or is under common Control with the relevant Party to this Agreement. " Control " or " Controlled " means the ownership of more than fifty per cent (50%) of the issued share capital or the legal power to direct or cause the direction of the general management and policies of the Party in question;

 

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

3


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

   

" Agreement "

 

means this Development and Supply Agreement and the Schedules hereto, as amended or varied from time to time by written agreement of the Parties;

 

 

 

" Batch "

 

means the total Product (Drug Substance) obtained from one fermentation and associated purification using the Process.  Batches which are to be produced in accordance with cGMP are also referred to as " cGMP Batches ";

 

 

 

" Batch Release "

 

means a release of any Batch by a Qualified Person for distribution or further processing confirming that the Batch is in accordance with the relevant requirements for human use (as defined in Directive 2001/83/EC for medicinal products for human use);

 

 

 

" Cell Line "

 

means the cell line controlled by Micromet and selected by Micromet for the production of the Product, particulars of which are set out in Schedule 1 ;

 

 

 

" CEO "

 

means chief executive officer;

 

 

 

" cGMP "

 

means current good manufacturing practices and general biologics products standards as promulgated under the European Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively; the International Committee for Harmonisation (ICH) Q7A Guideline on Good Manufacturing Practice for Active Pharmaceutical Ingredients; the U.S. Federal Food, Drug and Cosmetic Act found in Title 21 of the U.S. Code of Federal Regulations (CFR), including but not limited to Parts 210, 211 and Parts 11,  310 et seq., 600 to 610, the European Commission Guidelines of Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 2003/94/EC (Eudralex – Volume 4) and the respective Japanese directives and guidelines by the Japanese authorities, as applicable. Lonza meets EU GMP requirements as defined in Eudralex - Volume 4 Good Manufacturing Guidelines by the European Commission for medicinal products for human and veterinary use (EU-GMP Guidelines);

 

 

 

" cGMP Product "

 

means Product which is required under Schedule 2 to be manufactured in accordance with cGMP;

 

 

 

" COO "

 

means chief operating officer;

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

4


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

 

" Deliver ", " Delivered " or " Delivery " has the meaning given to it in Clause 6;

 

" Deliverables "

 

means the reports, documentation, information, material and Product which Lonza is to make available to Micromet during the Project. The Deliverables and the timelines to provide the Deliverables are set forth in the Project Plan in Schedules 8 A and 8 B hereto;

 

 

 

" Engineering Batch "

 

means the first Batch at scale after the pilot Batch in which Lonza will use commercially reasonable efforts but does not warrant to meet cGMP;

 

 

 

" External Laboratories "

 

means any Third Party instructed by Lonza, with Micromet’s consent, to conduct activities required to complete the Works and Services, including but not limited to, Third Parties that synthesise DNA or perform tests on the Cell Line, Product or materials derived therefrom; [***]

" Intellectual Property "/" IP "

 

means all intellectual property rights, including (without limitation) patents, patent applications, divisions, continuations, continuation-in-part applications, divisionals, substitutions, confirmations, supplementary protection certificates, reissues, utility models, trademarks, database rights and copyrights and all inventions, know-how, trade secrets, techniques and confidential information and other proprietary knowledge and information which may subsist anywhere in the world, in each case for their full term, and together with any renewals or extensions;

 

 

 

" Lonza "

 

means Lonza Sales AG and its Affiliates Lonza Biologics plc of Slough, England, Lonza Biologics Inc of Portsmouth, NH, USA, and Lonza Biologics Porriño S.L. of Pontevedra-Galicia, Spain, and their successors in title and lawful assigns;

 

 

 

" Lonza Confidential Information"

 

means and includes Lonza Technology, any trade secrets or other confidential information relating to Lonza's technology, business affairs or finances of Lonza, or of any suppliers, agents, distributors, licensees or other customers of Lonza and the commercial terms of this Agreement;

 

 

 

" Lonza Know How "

 

means all technical and other information relating directly or indirectly to the Lonza Process and/or the performance of the Works and Services, known to Lonza from time to time, other than Micromet Confidential Information, Micromet Know How and information in the public domain.  Without limiting the foregoing, the Lonza Know How is identified in Schedule 4 hereto;

    

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

5


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

      

" Lonza Patent Rights "

 

means all patents, patent applications, divisions, continuations, continuation-in-part applications, divisionals, extensions, substitutions, renewals, confirmations, supplementary protection certificates and reissues, throughout the world relating to the Lonza Process and/or the performance of the Works and Services which from time to time Lonza is the owner of or is entitled to use, and that is used in the performance of the Works and Services.  Without limiting the foregoing, the Lonza Patent Rights as of the Effective Date are listed in Schedule 5 hereto;

 

 

 

" Lonza Process "

 

means the proprietary process of Lonza, including any modifications and improvements, which is used for the manufacture of the Product hereunder;

 

 

 

" Lonza Technology "

 

means the Lonza Know How and the Lonza Patent Rights;

 

 

 

" [***] "

 

means  [***] ;

 

 

 

" [***] "

 

means the [***] Agreement between [***] and [***] dated [***] and attached hereto at Schedule 9;

 

 

 

" Micromet "

 

means Micromet AG and its existing Affiliates which are engaged in the research and development of BiTE ® antibodies, and their successors in title and lawful assigns;

 

 

 

" Micromet Confidential

 

 

Information "

 

means and includes Micromet Materials, Micromet Technology and the Results, any trade secrets or other confidential information relating to Micromet's technology, development strategies, business affairs or finances of Micromet, or of any licensors, suppliers, agents, distributors or other contractors of Micromet, and the commercial terms of this Agreement;

 

 

 

" Micromet Know How "

 

means all technical and other information relating directly or indirectly to the Micromet Process, the Cell Line and the Micromet Materials, known to Micromet from time to time, other than Lonza Confidential Information, Lonza Know How and information in the public domain.  Without limiting the foregoing, the Micromet Know How is identified in Schedule 6 hereto;

 

 

 

" Micromet Materials "

 

means the materials and documentation supplied by Micromet to Lonza (including but not limited to  [***] and  [***] ).  Without limiting the foregoing, the Micromet Materials to be transferred are listed in Schedule 1 hereto;

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

6


 

  

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

  

" Micromet Patent Rights "

 

means all patents, patent applications, divisions, continuations, continuation-in-part applications, divisionals, extensions, substitutions, renewals, confirmations, supplementary protection certificates and reissues, throughout the world relating to the Micromet Process, the Cell Line and the Micromet Materials which from time to time Micromet is the owner of or is entitled to use, and that is used in the performance of the Works and Services.  Without limiting the foregoing, the Micromet Patent Rights as of the Effective Date are listed in Schedule 7 hereto;

 

 

 

" Micromet Process "

 

means the process (including but not limited to the  [***] process and the  [***] process) for the production of Product which is owned or Controlled by Micromet and made available to Lonza hereunder for  [***] with the  [***] , further improvement and/or production of the Product;

 

 

 

" Micromet Technology "

 

means the Micromet Know How and the Micromet Patent Rights;

 

 

 

" [***] "

 

means any  [***] of  [***] , including  [***] and  [***] ;

 

 

 

" MT103 "

 

means Micromet's single-chain bispecific anti-CD19 antibody (CD19 BiTE ® ) also known as Blinatumomab;

 

 

 

" Party "/" Parties "

 

shall mean Lonza or Micromet, or Lonza and Micromet, as the context admits;

 

 

 

" Price "

 

means the price specified in Schedule 3 for the Works and Services;

 

 

 

" Process "

 

means the process used by Lonza for the production of Product from the Cell Line in accordance with this Agreement, which may combine elements of the Micromet Process and of the Lonza Process, and is modified and/or improved hereunder;

 

 

 

" Product "

 

means MT103 manufactured under this Agreement (including any sample thereof), particulars of which are set out in Schedule 1 and includes all derivatives thereof;

 

 

 

" Project "

 

means the program described in the Project Plan;

 

 

 

" Project Manager "

 

means a Party's representative who is responsible for the coordination and supervision of the Project in accordance with Clause 4.1 below;

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

7


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

   

" Project Plan "

 

means the plan describing all activities to be performed under this Agreement, including any update and amendment of the Project Plan the Parties may agree from time to time, and attached hereto as Schedules 8 A and 8 B ;

 

 

 

" Project Team "

 

means the working group described in Clause 4.2;

 

 

 

" Qualified Person "/" QP "

 

means a person confirming that the Batch is in accordance with the relevant requirements (as defined in Directive 2001/83/EC for medicinal products for human use);

 

 

 

" Results "

 

means the Product, any inventions, discoveries, know how, data, Deliverables, documentation, reports, materials, writings, processes, methods and other information, recorded in any form, that are discovered, conceived, reduced to practice, developed or otherwise generated by Lonza, which are related to the Works and Services and conceived through the performance of the Works and Services, and any Intellectual Property pertaining to any of the foregoing (including the  [***] Intellectual Property), provided, however, that "Results" shall exclude  [***] and  [***] Intellectual Property;

 

 

 

" Service Agreement "

 

means the agreement between the Parties dated September 28, 2009 regarding the  [***] of  [***]  for the production of Product using the  [***] and the  [***] ;

 

 

 

" Specifications "

 

means the specifications for Drug Substance.  The Specifications and the specifications for Drug Product regarding the testing of Drug Product by Lonza are set out in Schedule 2 ;

 

 

 

" Steering Committee "

 

means the committee described in Clause 4.3;

 

 

 

" Terms of Payment "

 

means the terms of payment specified in Schedule 3 ;

 

 

 

" Third Party "

 

means any party other than Lonza and Micromet;

 

 

 

" Works and Services "

 

means all or any part of the works and services which are the subject of this Agreement, particulars of which are set out in Schedules 8 A and 8 B .

 

References to the singular number include the plural and vice versa, references to Clauses and Schedules are references to clauses and schedules to this Agreement.

    

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

8


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    
    

2.

Provision of the Works and Services

 

2.1

Lonza shall diligently carry out the Works and Services as provided in Schedule 8 A – and in Schedule 8 B , once it is finalized - and shall use all reasonable efforts to achieve the estimated timescales set out in that Schedule.  The Parties agree that the Works and Services set forth in Schedule 8 B are rough estimates only, and the Parties shall updated and refine such Schedule 8 B after the transfer of the Micromet Materials and establishment of the Process at Lonza.  Lonza shall perform the Works and Services under this Agreement according to the current industry standards and subject to terms and conditions as set out herein.  Lonza shall at all times use reasonable and adequate safety and protection measures to ensure, as far as is reasonably possible, that the Results are not endangered by an interruption of Lonza's research and development activities.

 

2.2

Lonza shall do all that is reasonably possible to meet the objectives under the Project Plan, including diligence obligations and commercially reasonable flexibility regarding alternative work packages and capacity reservations under this Agreement.

 

2.3

Micromet shall make available to Lonza a data package comprising the Micromet Know How which is reasonably required to perform the Works and Services and the Parties shall collaborate to assist Lonza in evaluating such Micromet Know How.  Without undue delay upon completion of the Services Agreement and delivery of such Micromet Know How, however, no later than within  [***]  thereafter, Lonza shall inform Micromet whether the  [***] , the  [***]  and the  [***]  meet the particulars set out in Schedule 1 and are suited for the performance of the Works and Services hereunder.  If the  [***] , the  [***]  and/or the  [***]  do not meet the particulars set out in Schedule 1 , Lonza and Micromet shall enter into good faith discussions in order to identify a  [***] , a  [***]  or other  [***]  for the Works and Services and to agree on the terms and conditions and adjustments to the Project Plan to minimize any delay.  If the Parties are unable to agree on an  [***]  or  [***]  and the terms and conditions to use such  [***] or  [***] within  [***]  after completion of the later of (i) completion of services under the Services Agreement or (ii) transfer of the Micromet Materials and Micromet Technology,  [***] shall have the option to  [***] in accordance with  [***] and without further  [***] or to  [***] under  [***]

 

2.4

Lonza shall manufacture cGMP Product to meet the Specifications provided that there shall be  [***] to meet the Specifications in respect of the [***] and the  [***]  manufactured or in respect of the  [***] following any change in the  [***] .  If the  [***]  or a combination of the  [***]  and the  [***]  is used, then in addition to the above, Lonza shall be under no obligation to meet certain  [***] in  [***]  in respect of  [***] until a  [***] does meet  [***] .  In the event the  [***]  does not meet the Specifications, the Parties shall promptly meet through the Steering Committee to discuss and agree on how to ensure that the Specifications can be met, which agreement may include a modification of the Project Plan.

 

2.5

Owing to the unpredictable nature of the biological processes involved in the Works and Services, the timescales set down for the performance of the Works and Services (including without limitation the dates for production and Delivery of Product) and the quantities of Product for Delivery set out in Schedules 8 A and 8 B are estimated only.  In the event any Party realizes that the Project Plan needs to be changed, e.g., for a delay of Works and Services owing to technical or scientific difficulties, such Party shall immediately inform the Project Team hereof and the Parties, through the Steering Committee (if needed), shall use commercially reasonable efforts to come to an adequate solution and agree on an adequate amendment of the Project Plan.  In particular, Lonza will use commercially reasonable efforts to  [***]  as early as possible, in the event any of the  [***] , provided always that   [***]  are taken into account.

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

9


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    
    

2.6

Lonza will use its reasonable efforts to perform any additional work which may become necessary to manufacture Product for  [***] .  If such additional work leads to additional costs, Lonza will provide a quotation for such additional work.  In case the Parties agree on the additional work and the costs for such additional work, Lonza shall perform additional work to sustain the progress of the Project on terms and conditions to be agreed by the Parties and defined in an amendment to the Project Plan.  If further quantities of Product are required for  [***]  which are not part of this Agreement, the Parties will discuss in good faith how Lonza can satisfy Micromet's needs for such additional quantities.

 

2.7

Without prejudice to Lonza’s obligations under Clauses 2.1 and 2.2 and the termination rights under Clause 12, Micromet  [***]  of the Works and Services or to  [***] the Works and Services on grounds of late performance, late Delivery or failure to produce the estimated quantities of Product for Delivery.  Lonza shall not be liable for any loss, damage, costs or expenses of any nature, whether direct or consequential, occasioned by:

 

(a)            [***] ; or

 

(b)            [***] .

 

However, and to the extent, that (i) a  [***] to  [***] the  [***] of  [***] for  [***] , or (ii) the  [***] are  [***] to  [***] by  [***] the  [***] on  [***]   [***] .

 

2.8

Lonza shall comply with all applicable laws and regulations regarding the cGMP production, including but not limited to the EU-GMP Guidelines (Eudralex – Vol. 4), FDA regulations, Japanese regulations and the International Committee for Harmonisation regulatory requirements from time to time applicable to the Works and Services as set out in Schedules 8 A and 8 B .

 

2.9

Lonza shall not use the Cell Line, the Process (not including the Lonza Process), the Micromet Materials or the Micromet Technology (or any part thereof) for any purpose other than the performance of the Works and Services under this Agreement.

 

2.10 

Lonza shall:

 

 

(a)

at all times use all reasonable endeavours to keep the Cell Line and/or the Micromet Materials secure and safe from loss and damage in such manner as Lonza stores its own material of similar nature during the term of this Agreement, and obtain and maintain an appropriate insurance against the risks of loss and damage;

 

 

(b)

during the performance of the Works and Services, inform Micromet as soon as reasonably possible upon request about all ongoing activities;

 

 

(c)

not part with possession of the Cell Line and/or the Micromet Materials or the Product, save for the purpose of activities at the External Laboratories or as otherwise authorised in writing by Micromet;

 

 

(d)

store Micromet Materials in accordance with applicable laws, industry standards and the specifications set forth in Schedule 1 , furthermore, store the Cell Line and the cell banks ( [***] and  [***] ) at at least two (2) different and controlled sites under cGMP conditions;

 

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 

10


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    
   

 

(e)

audit all External Laboratories in accordance with GxP guidelines and confirm the performance of such audit to Micromet in writing; and

 

 

(f)

procure that all External Laboratories are subject to obligations of confidence substantially in the form of those obligations of confidence imposed on Lonza under this Agreement.

 

2.11

Lonza will not (i) directly or indirectly, take any steps to ascertain the  [***] of any  [***]  provided by Micromet and or a  [***] , and (ii) use Micromet's  [***]  for any purpose other than manufacturing the Product.  In the event Lonza ascertains or receives the recipe of any of Micromet's  [***]  through no fault of its own, Lonza shall promptly inform Micromet of such event and destroy such information.

 

2.12

Lonza and Micromet will exchange details of the  [***]  in order to  [***]  that will be used  [***] .  Lonza will obtain Micromet's consent regarding its  [***] , which Micromet shall not unreasonably withhold.  Lonza shall use reasonable commercial endeavours to ensure continuity of supply, through the  [***] of a  [***]  where possible,  [***] establishment  [***] second source  [***] same supplier (e.g. second production site)  [***] establishment  [***] supply  [***] emergency plan/security stock.

 

2.13

Lonza agrees to maintain proper records (the " Records ") in respect of its performance of the Works and Services, including any Results made as part of the Works and Services.  Upon written request by Micromet, Lonza shall provide copies of the Records or any part(s) thereof, redacted with regards to  [***]  and  [***]  to Micromet.  As part of keeping the Records, Lonza shall ensure that all of its personnel and all of its agents abide by the regulations of the International Committee for Harmonisation as per Clause 2.8.

 

2.14

Lonza shall:

 

 

(a)

make available to Micromet the Deliverables set forth in the Project Plan;

 

 

(b)

make available to Micromet (i) upon completion of any milestone as outlined in the Project Plan and or (ii)  [***] of the  [***] of the Works and Services and upon reasonable request of Micromet, (i.e., if Micromet requires such documentation for regulatory purposes or for own development purposes and provided that such documentation – in Lonza's reasonable opinion – is accurate); copies of all relevant documentation and information resulting from the Works and Services and relating to the Product in order to enable Micromet to evaluate the status and to meet any statutory or regulatory requirements.  The documentation and information shall be provided in the CTD format.  The documentation and information shall include but not be limited to the  [***] of  [***] and the  [***] , a  [***] of  [***] of the  [***] , a  [***] , including a  [***] and a [***] issued by and in responsibility of a  [***] ,  [***] of  [***] and the  [***] of  [***] for the  [***] or equivalent in other  [***] ) in  [***] and for  [***] of such  [***] to the  [***] .  For the avoidance of doubt, the preceding sentence does not require  [***] to provide  [***] with  [***] of the  [***] or other  [***]  except if requested by  [***] ; [***]

 

 

(c)

support IND updates and CTAs as well as the submission of dossiers for NDA/MAA approval;

 

 

(d)

make available to Micromet, upon completion of each stage as outlined in the Project Plan and upon request of Micromet, material ( [***] and the like) resulting from the Works and Services in order to enable Micromet to test the supernatant, antibody, cells, Product, and the like;

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

11


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

       

 

(e)

assist Micromet in respect to regulatory requirements concerning the CMC-part, including but not limited to the  [***] for  [***] and  [***] ;

 

 

(f)

reasonably support Micromet regarding regulatory matters.  Such support shall include an obligation to make Micromet aware of any specific regulatory requirements relating to Lonza’s activities, to accompany Micromet to meetings with the regulatory authorities upon  [***]  prior written notice by Micromet (or use reasonable commercial endeavours to support Micromet where shorter notice is provided by a regulatory authority), to prepare such meetings jointly with Micromet, and to actively participate in scientific advice meetings; and

 

 

(g)

promptly inform Micromet about any existing or potential future issues with  [***] that  [***] regarding any  [***] or  [***] used  [***]

 

 

The Deliverables and the provision of the Deliverables are defined in more detail in the Project Plan.

 

2.15

Lonza shall from time to time offer to Micromet  [***] of its  [***] and  [***]  (as identified in Schedule 4).  Such new version shall be made available at the price set forth in the Technology Transfer and License Agreement in Schedule 14 hereto, if applicable, with the only further compensation being for additional Works and Services which may be required to implement such improvement or new version for the manufacture of the Product.

 

2.16

Any subcontracting of Works and Services to be performed hereunder by Lonza to Third Parties requires the prior written consent of Micromet.

  

3.

Micromet's Obligations

 

3.1

Following the Effective Date (if not already forwarded to Lonza during the Services Agreement) and upon conclusion of  [***] the  [***] of some of the  [***] and  [***]  attached hereto as Schedule 9 , Micromet shall supply to Lonza the Micromet Know How, together with full details of any hazards relating to the Cell Line, the Micromet Process and/or the Micromet Materials, their storage and use, in each case, to the extent required by Lonza to perform the Works and Services.  For the avoidance of doubt, the  [***]  is embodied in the  [***] the  [***] and the  [***]  and is not disclosed as a separate set of documents.  On review and approval by Lonza’s safety committee of this Micromet Technology, the Cell Line, the Micromet Process and/or the Micromet Materials shall be provided to Lonza at Lonza’s request.  Property in the Cell Line, the Micromet Process and/or the Micromet Materials and/or the Micromet Technology supplied to Lonza shall remain vested in Micromet.

 

3.2

Unless the Parties agree otherwise during the term of this Agreement, Micromet or Micromet's Third Party supplier will supply to Lonza the  [***] and  [***]  necessary for the manufacture of Product.  Lonza shall not, directly or indirectly, take any steps to  [***] the  [***] of any such  [***] and  [***]  provided by Micromet.   Similarly, should the Lonza Process be used in the manufacture of the Product, Micromet shall not, directly or indirectly, take any steps to  [***] the  [***] of any  [***] and  [***]  provided by Lonza.

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

12


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

  

3.3

Micromet shall pay the Price set out in Schedule 3 for provision of the Works and Services together with any additional costs and expenses that fall due under this Agreement in accordance with the Terms of Payment.

 

3.4

Micromet hereby grants Lonza the non-exclusive right to use the Cell Line, the Micromet Process, the Micromet Materials, and the Micromet Technology during the term of this Agreement and solely for the purpose of this Agreement.  Micromet acknowledges that Lonza does not require a separate licence to Micromet Confidential Information as all necessary licences are contained in the first sentence of this clause 3.4.

 

3.5

From time to time, as soon as reasonably possible and with at least  [***]  advance notice, Lonza may submit to Micromet a written request to provide or have provided consulting services to Lonza with respect to the Micromet Process, which request will include the specifics of the consulting services being requested, and Micromet will use reasonable efforts to provide or have provided such consulting services.

 

4. 

Governance

 

4.1

Designation of Project Manager:   Lonza and Micromet shall each identify a Project Manager who will be responsible for the coordination and supervision of the Project including communication of all instructions and information concerning the Project to the other Party.  A written protocol of such communication shall be provided by the Project Managers.  Each Project Manager will be available on an agreed weekly basis for consultation at prearranged times during the course of the Project.  In the absence of the Project Manager, a substitute shall be appointed.  Additional modes or methods of communication and decision making may be implemented with the written consent of each Party.

 

4.2

Project Team:   The Parties shall form a Project Team to which Micromet will delegate professionally and technically qualified representatives (e.g., qualified in upstream process, downstream process, analytics, quality assurance and regulatory matters).  Each Project Team member shall have knowledge and ongoing familiarity with the Project and will possess the authority to make decisions on matters raised in the Project Team.  Each Party shall have the right to substitute different representatives as its members of the Project Team as needed from time to time.  Each Party shall also be entitled to invite other employees as ad hoc guests to address specific technical or commercial issues related to the Project.  Consultants of a Party or other Third Parties may be invited, provided that they are bound by a confidentiality obligation which is substantially similar to the Parties' obligations under Clause 10 below.

 

The Project Team shall meet within  [***]  after written request for such meeting by either Party, or sooner, if required, and meetings shall take place on a  [***] , and at least one face-to-face meeting shall take place  [***] .

 

 

The Project Team shall oversee the Project.  Prior to each meeting of the Project Team the Parties will distribute to each other written copies of all materials, data and information arising out of the conduct of their activities hereunder.  Unless otherwise agreed, Lonza shall present any suggestions regarding the Project Plan and/or specifications of the Project to the Project Team for discussion and approval by Micromet.

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

13


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

      

 

Each Party shall bear its own travel and accommodation costs.  The meetings of the Project Team may also be held by telephone or video conference if mutually agreed by the Project Team members.  It is the right of each Party to call for a Project Team meeting upon written request at any time.  In that case the meeting will be held at a time and location to be agreed between the Project Team members.

 

 

The inviting Party shall prepare minutes of the meeting which shall be circulated promptly following the meeting.

 

4.3

Steering Committee:   The Parties shall form a Steering Committee to which each Party will delegate two (2) executive employees, who are familiar with the Project.  The Steering Committee shall have general oversight and review of the activities of the Project Team and shall be responsible for resolving any issues referred to the Steering Committee by the Parties.

 

 

The Steering Committee shall meet in person or via teleconferences within  [***]  after a written request by either Party to the other Party, or sooner, if required, and calendar quarterly, if possible towards the end of a stage of the Project.  The request shall describe the matter in dispute and the solution which the requesting Party proposes to be decided.

 

 

The Steering Committee will take action by unanimous consent of its members, with each representative having a single vote, or by a written resolution signed by all of the representatives.  If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter will be referred to a personal face-to-face meeting between Lonza's  [***]  and the  [***]  of Micromet, who in each case may not be a member of the Steering Committee and both of whom shall act in good faith and discuss the issue to seek a resolution amicably acceptable to both Parties and if resolved the resolution shall be binding and final.  The meeting shall take place within  [***]  of the relevant referral.  In case such persons cannot agree within further  [***]  after such face-to-face meeting, then the following shall apply:

 

 

(i)

If the dispute is predominantly concerned with scientific or technical issues then the entire dispute shall be referred to independent experts on who the Parties agree as set forth hereinafter:  Each Party is entitled to propose one (1) independent expert and the other Party shall not unreasonably withhold its consent to the appointment of such expert.  The Parties will make available the same set of documents to both experts and both experts shall provide their expert opinion in English language within  [***]  after the second expert has been appointed.  If the two (2) experts come to dissenting opinions and are unable to solve the dispute among themselves, a third expert shall be appointed either jointly by the Parties or by the President of the German Association of the Pharmaceutical Industry (Bundesverband der Pharmazeutischen Industrie, BPI), if the Parties cannot agree, who is an expert in the particular scientific or technical area at issue and who shall act as an expert and not an arbitrator.  Such third expert shall have access to the written opinions of the two other experts as well as to all documents which were made available to the two experts.  The third expert shall then approve either one of the two opinions of the first two experts, and such opinion approved by the third expert shall be considered final and binding on the Parties except if there has been a manifest error on the face of the decision whereupon the Parties may revert to their respective remedies under Clause 16 below.  The reasonable costs of the experts shall be paid or refunded, as the case may be, by the non-prevailing Party.

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

14


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

     

 

(ii)

If the dispute is predominantly concerned with an issue other than scientific or technical then it shall be resolved in accordance with Clause 16 below.

 

5. 

Inspections; Person in Plant

 

5.1

As more fully set out in the Quality Agreement in Schedule 10 hereto, Lonza grants to Micromet and/or its consultant the right to inspect and audit Lonza's Affiliate’s facility located in Slough, Berkshire, United Kingdom (" Facility ") as well as the documentation generated in connection with the manufacture and testing of Product including all relevant standard operating procedures.  Lonza grants the right to perform  [***] standard cGMP compliance audit per year, not to exceed  [***] and  [***]  at a time mutually agreed between Micromet and Lonza.  Micromet can perform  [***]  cGMP batch documentation audit per cGMP batch which would be scheduled as appropriate in the project plan.  Moreover, Micromet is entitled to perform additional audits in the event of complaints, major or critical deviations or other enquiries by regulatory authorities without any fee, and if necessary, on short-term notice.  Micromet will discuss the results of any inspection with Lonza.  Any inspection by Micromet does not relieve Lonza of its obligations to comply with all applicable laws and does not constitute a waiver of any right otherwise available to Micromet.  As more fully set out in Clause 5.3,  [***]  is also entitled to attend all production campaigns of the Product at the Facility.

 

5.2

As more fully set out in the Quality Agreement in Schedule 10 hereto, an employee and/or consultant and /or successor of Micromet or Micromet’s sublicensee(s) of the Product will have the right to be present as a silent observer at any announced visit to Lonza by any regulatory authority relating to the manufacture of Product for clinical trials. Furthermore, Lonza will inform Micromet of the results of any inspection by a regulatory authority (subject to any restraints placed on Lonza by such regulatory authority, Lonza Confidential Information which Micromet does not require for purposes of this Agreement or customer confidentiality) that does or could reasonably be expected to affect the manufacture of Products.

 

5.3

Lonza agrees to have an employee or consultant of Micromet be present at the Facility in order to observe the Works and Services performed by Lonza or its Affiliate (" Person-in-Plant " or " PiP ") in accordance with this Clause 5.3.  Upon request of Micromet, Lonza shall grant the PiP access to the Facility where the Works and Services are performed.  Such visits, shall last not longer than  [***] , will take place no more than  [***] a  [***]  during regular business hours and upon  [***]  prior notice to Lonza, provided, however, that PiP will be entitled to perform additional visits that could last up to the full length of a cGMP Batch's (and/or consolidation and/or pilot Batch's) manufacturing process subject to Lonza’s consent not to be unreasonably withheld or delayed, and further provided that PiP will be entitled to perform visits upon immediate notice in the event of complaints or failures which may endanger the Project.

 

5.4

Notwithstanding Clauses 5.1, 5.2 and 5.3, Micromet acknowledges and accepts that the Facility is a multi-customer facility, and that the PiP’s movement about and access to the Facility may be restricted and shall be subject to supervision by Lonza.

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

15


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

  

6. 

Delivery, Transportation of Product and Testing

 

6.1

Subject to Clause 2.4, Product shall be Delivered in accordance with the Specifications.  Delivery shall be made  [***]  (as defined by Incoterms 2000) which means (a) when  [***] places  [***] at the  [***] at  [***] and  [***]  and (b) risk and title to Product pass  [***] .  Subject to Clause 6.2, Lonza shall deliver to Micromet the Certificate of Analysis, the Certificate of Compliance, issued by and in responsibility of a Qualified Person (Batch Release) and such other documentation as is reasonably required to meet all applicable statutory and regulatory requirements not later than the date of Delivery.  Transportation of Product, whether or not under any arrangements made by Lonza on behalf of Micromet, shall be made at the  [***] of  [***] .

 

6.2

At Micromet's request, Lonza will Deliver Product  [***] prior to delivery of the  [***] and the  [***]   Such request shall be accompanied by Micromet's written acknowledgement that the Product has been Delivered without the transmittal to Micromet of the Certificate of Analysis and the Batch release documents (QP release), that accordingly the Product cannot be administered to humans until transmittal of the Certificate of Analysis, Certificate of Compliance (possibly in one document) and the Batch release documents (QP release) and that Micromet nevertheless accepts full risk of loss, title and ownership of the Product.  The Delivery of Product in quarantine shall be subject to such testing requirements as Lonza may reasonably require, and the  [***]  period referred to in Clause 6.9 shall run from Delivery in quarantine of the Product to Micromet.

 

6.3

Unless otherwise agreed, Lonza shall package and label Product for Delivery in accordance with its standard operating procedures.  It shall be the responsibility of Micromet to inform Lonza in writing in advance of any special packaging and labeling requirements for Product.  All additional costs and expenses of whatever nature incurred by Lonza in complying with such special requirements shall be charged to Micromet in addition to the Price.

 

6.4

If requested in writing by Micromet, Lonza will (acting as agent for Micromet) arrange for storage in accordance with the storage conditions in Schedule 1 and for insurance of Product whilst held by Lonza after Delivery (awaiting transportation) for up to  [***]  after QP release of the Batch, and in exceptional cases for a maximum of  [***] , on terms equivalent to those under which Lonza stores and insures product prior to Delivery.  All additional costs and expenses of whatever nature incurred by Lonza in arranging such storage and insurance shall be charged to Micromet in addition to the Price.

 

6.5

If requested in writing by Micromet, Lonza will (acting as agent of Micromet for such purpose) arrange the transportation of Product from Lonza’s premises to the destination indicated by Micromet together with insurance cover for Product in transit at its invoiced value.  All additional costs and expenses of whatever nature incurred by Lonza in arranging such transportation and insurance shall be charged to Micromet in addition to the Price.

 

6.6

Where Lonza has made arrangements for the transportation of Product, Micromet shall diligently examine the Product as soon as practicable after receipt.  Notice of all claims (time being of the essence) arising out of:

 

 

(a)

visible damage (i.e., visible without inspection and testing) to or total or partial loss of Product in transit shall be given in writing to Lonza and the carrier within  [***]  of receipt by Micromet; or

 

 

(b)

non-Delivery shall be given in writing to Lonza within  [***]  after the date of Lonza’s dispatch notice.

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
   

 

16


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

    

6.7

Any Product Delivered hereunder shall, at the time of Delivery conform to the Specifications (subject to Clause 2.4 above) and have been manufactured in accordance with cGMP (not including the pilot Batch and Engineering Batch) and applicable laws.  Lonza and Micromet shall use all commercially reasonable efforts to resolve a non-conformity issue and resume re-delivery of Products at the earliest time possible.  Any dispute regarding the conformity of Products which cannot be settled within  [***]  after receipt of a detailed written notice of rejection shall be submitted for resolution to the Steering Committee.

 

6.8

Micromet shall make damaged Product and associated packaging materials available for inspection and shall comply with the requirements of any insurance policy covering the Product notified by Lonza to Micromet.  Lonza shall offer Micromet all reasonable assistance (at the cost and expense of Micromet) in pursuing any claims arising out of the transportation of Product.

 

6.9

Promptly following receipt of Product or any sample thereof, Micromet may carry out any of the agreed tests outlined or referred to in Schedule 11 .  Subject to Clause 2.4, if such tests show that the Product fails to meet Specifications, Micromet shall give Lonza written notice thereof within  [***]  from the date of Delivery and shall return samples of such Product to Lonza’s premises for further testing and Micromet shall store the remainder of Product in quarantine.  In the absence of such written notice and subject to any hidden defect which did not appear in the tests carried out by Micromet in accordance with Schedule 11 , Product shall be deemed to have been accepted by Micromet as meeting the Specifications.  Subject to Clause 2.4, if Product returned to Lonza fails to meet the Specifications and if such failure is not due (in whole or in part) to acts or omissions of Micromet or any Third Party after Delivery,  [***] shall at  [***] discretion  [***] that  [***] to  [***] of such  [***] or  [***] and  [***] and further  [***] all  [***] regarding the  [***] to  [***] In the event  [***] to  [***] such  [***] shall use  [***] to  [***] with the  [***] to its  [***] to  [***] in the  [***] .

 

6.10

Subject to Clause 2.4, if there is any dispute concerning whether Product returned to Lonza fails to meet the Specifications or whether such failure is due (in whole or in part) to acts or omissions of Micromet or any Third Party after Delivery, such dispute shall be referred for decision to an independent expert (acting as an expert and not as an arbitrator) to be appointed and paid in accordance with Clause 4.3 (i) above.

 

6.11

The provisions of Clauses 6.9 and 6.10 shall be the sole remedy available to Micromet in respect of Product that fails to meet the Specifications.

 

7. 

Price and Terms of Payment

 

7.1

Unless otherwise indicated in writing by Lonza, all prices and charges are exclusive of Value Added Tax or of any other applicable taxes, levies, imposts, duties and fees of whatever nature imposed by or under the authority of any government or public authority, which shall be paid by Micromet (other than taxes on Lonza’s income).  Payments shall be made in accordance with the Terms of Payment in Schedule 3 hereto.  Lonza will provide to Micromet in regular intervals upon amendments to the Project Plan updated payment plans.  All invoices are strictly net and payment must be made within  [***]  of date of invoice.  Payment shall be made without deduction, deferment, set-off, lien or counterclaim of any nature.

   

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

17


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

  

7.2 

In default of payment on due date:

 

 

(a)

interest shall accrue on any amount overdue at the rate of  [***]  above the base lending rate from time to time of National Westminster Bank plc, interest to accrue on a day to day basis both before and after judgment; and

 

 

(b)

Lonza shall, at its sole discretion, and without prejudice to any other of its accrued rights, be entitled to suspend the provision of the Works and Services or to treat this Agreement as repudiated on not less than  [***]  prior notice in writing to Micromet given at any time thereafter.

 

8. 

Intellectual Property

 

8.1

Neither Party will, as a result of this Agreement, acquire any right, title, or interest in any Intellectual Property that the other Party owns or Controls as of the Effective Date, or that the other Party obtains ownership or Control of separate and apart from the performance of the Works and Services under this Agreement.

 

8.2

[***] acknowledges and agrees that, subject to Clause 8.3, any and all  [***] shall  [***] shall promptly and fully  [***] all  [***] to  [***] and  [***] to  [***] that  [***] and  [***] or  [***] may  [***] and  [***] and  [***] to  [***] to the  [***] of  [***] and  [***]

 

8.3

[***]  shall own all right, title and interest in  [***]  which as used in this Agreement means Intellectual Property that  [***] , contractors or agents develops, conceives, invents, reduces to practice or makes in the course of performance of the Works and Services and that (i) arises from or relates to  [***]  or  [***] ; and (ii) is severable from the  [***]  and  [***] ; and (iii) does not reveal or disclose the  [***] , or Works and Services performed under this Agreement.   [***]  shall provide  [***]  with a general description of any  [***] Intellectual Property in the event that any is developed, in order to enable  [***]  to make an assessment as to whether  [***]  would like to use the  [***] Intellectual Property under the  [***] .

 

8.4

Except for and not including the  [***] Intellectual Property, Micromet shall own all right, title, and interest in any and all  [***] and  [***] that  [***] conceives, invents, reduces to practice, develops or makes, solely or jointly with Micromet or others, in the course of performance of the Works and Services or as a result of  [***] of  [***] or  [***] (collectively, the " [***] Intellectual Property "). [***] hereby assigns and transfers to Micromet and shall continue to assign and transfer to  [***] of its right, title and interest in any  [***] Intellectual Property, and  [***] hereby accepts such assignment and transfer. [***] shall promptly disclose  [***] in writing all  [***] Intellectual Property. [***] shall execute, and shall require  [***] personnel  [***] to execute, any documents required to confirm  [***] ownership of the New  [***] Intellectual Property, and any documents required to apply for, maintain and enforce any patent or other right in the  [***] Intellectual Property.  Upon  [***] request and at  [***] and at  [***] shall assist  [***] as may be necessary to apply for, maintain and enforce any patent or other right in the [***]  Intellectual Property.  For the avoidance of doubt, the Parties agree that the term " [***] Intellectual Property" shall not under any circumstances be interpreted or defined to include any " [***] Intellectual Property".

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
   

 

18


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

   

8.5

In relation only to the  [***]  and  [***]  (and no other product),  [***]  hereby grants  [***] , and  [***]  hereby accepts  [***]  under and to all  [***] Intellectual Property, to the extent such  [***] Intellectual Property are necessary or useful to research, develop, have developed, conduct clinical trials for, formulate, manufacture, have manufactured, test, seek regulatory approval for, market, have marketed, commercialize, have commercialized, make, have made, use, sell, have sold import, have imported and distribute and have distributed  [***]  or  [***] .  For the avoidance of doubt, the nature of the above exclusive licence is as follows:

 

 

·

[***]  ownership of  [***] Intellectual Property as set out  [***]  is not affected;

 

 

·

[***]  use of the  [***] Intellectual Property is limited to use on the  [***]  and  [***] ; and

 

 

 

·

[***]  can grant further licences of the  [***] Intellectual Property to any third party, but may not do so in relation to the  [***]  and the  [***] .

 

 [***]  is entitled to  [***] to (i) Third Parties registered and operating, with respect of the manufacturing of Product,  [***]  and (ii) Third Parties  [***]   [***]  assessed and approved by  [***]  on a case-by-case basis, such approval by  [***]  not be unreasonably withheld or delayed.   [***]  shall execute all documents, give all declarations regarding the licenses granted under this Clause 8.5 and reasonably cooperate with  [***]  to the extent such documents, declarations and/or cooperation are required for the recordal or registration of the licenses granted hereunder at the various patent offices for the benefit of  [***]  and at  [***]  cost.

 

8.6

The Parties shall reasonably assist each other in defending themselves against a Third Party claim which would impair the exploitation of  [***]  Patent Rights,  [***] Intellectual Property and/or  [***]  Intellectual Property for the production of the Product.  Each Party shall furnish the other with timely written notice of any and all infringements and other unauthorized uses by any other person, firm, corporation or other entity of any of  [***]  Patent Rights,  [***] Intellectual Property or  [***] Intellectual Property.  Furthermore, the Parties shall promptly inform each other in the event either Party receives notice from any Third Party or becomes otherwise aware that the  [***]  Patent Rights, the  [***] Intellectual Property or the  [***] Intellectual Property may infringe Third Party Intellectual Property.

 

8.7

In relation only to the  [***]  and  [***]  (and no other product), to the extent that Lonza Technology (a) is incorporated within the  [***]  or  [***] , or (b) has been used in the manufacture of the  [***]  or  [***] , Lonza hereby grants Micromet, and Micromet hereby accepts a  [***]  license under and to Lonza Technology, to research, develop, have developed, conduct clinical trials for, formulate, manufacture, have manufactured, test, seek regulatory approval for, market, have marketed, commercialize, have commercialized, make, have made, use, sell, have sold import, have imported and distribute and have distributed  [***]  or  [***] .  For the avoidance of doubt, the nature of the above licence is as follows:

 

 

(i)

Lonza’s ownership of Lonza Technology is not affected, and except as set out in item (iv) below,  [***] ;

 

 

(ii)

There is no  [***]  to Micromet;

 

 

(iii)

Micromet’s use of the Lonza Technology is limited to use on the Product and Modified Product; and

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

19


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

    

 

(iv)

Lonza shall not  [***] in relation to the  [***] and the  [***] .

 

9. 

Warranties and Indemnification

 

9.1 

Lonza warranty:   Lonza warrants that:

 

 

(a)

the Works and Services shall be performed in accordance with Clause 2;

 

 

(b)

unencumbered title (save for any Intellectual Property which may exist) to Product and Results will be conveyed to Micromet upon Delivery;

 

 

(c)

on the Effective Date the Lonza Technology is owned by Lonza or Lonza is otherwise entitled to use it for the purposes of providing Works and Services under this Agreement and during the term of this Agreement Lonza shall not do or cause anything to be done which would adversely affect their ownership or entitlement to use the same for those purposes;

 

 

(d)

Lonza has the necessary corporate authorisations to enter into this Agreement;

 

 

(e)

on the Effective Date and to the best of Lonza's knowledge and belief in the context of absence of data regarding the Micromet Process, the estimated timescales, dates for production, delivery etc., as set out in the Project Plan, are realistic, provided, however, that Micromet reasonably cooperates with Lonza and provides the permissions necessary to progress, and Lonza has the resources available which are required to perform the Works and Services in a timely manner;

 

 

(f)

on the Effective Date and to the best of Lonza's knowledge and believe in the context of absence of data regarding the Micromet Process, no additional work is required to achieve the Deliverables;

 

 

(g)

on the Effective Date to the best of Lonza’s knowledge and belief, the use by Lonza of the Lonza Process (excluding any modifications or steps made or developed by Micromet, the Micromet Materials and Micromet Technology) and Lonza Technology for the performance of the Works and Services as provided herein will not infringe any rights (including without limitation any intellectual or industrial property rights) vested in any Third Party ( provided, however, that Micromet shall waive any breach of this warranty which arises if a court of competent jurisdiction determines that the use by Lonza of the Lonza Process, the Lonza Technology for the Works and Services infringes the Intellectual Property of a Third Party, provided that and for so long as Lonza actually indemnifies Micromet pursuant to Clause 9.4 below);

 

 

(h)

subject to Clause 2.4, the Product will meet the Specifications;

 

 

(i)

Lonza shall not use the Micromet Confidential Information, Micromet Materials, the Micromet Technology, the Process and the  [***] Intellectual Property for any purposes other than the Works and Services to be performed for Micromet hereunder; and

 

 

(j)

Lonza will notify Micromet in writing immediately if it receives or is notified of a claim from a Third Party that the use by Lonza of the Process and/or the Lonza Technology or  [***] Intellectual Property for Works and Services infringes any Intellectual Property vested in such Third Party.

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  

 

20


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

    

9.2 

Micromet warranty:   Micromet warrants that:

 

 

(a)

on the Effective Date to the best of Micromet's knowledge and belief, Micromet has the right to supply the Cell Line, the Micromet Process, the other Micromet Materials and the Micromet Technology to Lonza and the necessary rights to licence or permit Lonza to use the same for the purpose of the Works and Services;

 

 

(b)

Micromet has the necessary corporate authorisations to enter into this Agreement;

 

 

(c)

any of the Cell Line, the Micromet Process, other Micromet Materials, and Micromet Technology not owned by Micromet are licensed to Micromet under a licence which will permit their use by Lonza to perform the Works and Services;

 

 

(d)

Micromet has the right to disclose the Micromet Confidential Information and to allow the use of the Micromet Confidential Information by Lonza for the purposes of and in accordance with the terms of this Agreement, and the disclosure of the Micromet Confidential Information from Micromet to Lonza and the use of such Micromet Confidential Information by Lonza in accordance with the terms of this Agreement does not constitute  [***] ;

 

 

(e)

Micromet has agreed to indemnify  [***]  regarding the transfer of Micromet Technology and Micromet Materials and such indemnification obligations correspond to (or go beyond) the obligations in Section 3.6 of the  [***] ;

 

 

(f)

on the Effective Date and to the best of Micromet's knowledge and belief, the timescales as set out in the Project Plan are realistic and Micromet will be able to provide the Micromet Technology and the Micromet Materials to perform the Works and Services in a timely manner;

 

 

(g)

on the Effective Date and to the best of Micromet's knowledge and belief, no additional work is required to achieve the Deliverables;

 

 

(h)

on the Effective Date and to the best of Micromet's knowledge and belief, the use by Lonza of the Cell Line, the Micromet Process, other Micromet Materials and the Micromet Technology for the Works and Services (including without limitation the manufacture of the Product and excluding any modifications or steps made or developed by Lonza and the Lonza Technology) will not infringe any Intellectual Property of any Third Party ( provided, however, that Lonza shall waive any breach of this warranty which arises if a court of competent jurisdiction determines that the use by Lonza of the Cell Line, other Micromet Materials or the Micromet Technology for the Works and Services infringes the Intellectual Property of a Third Party, provided that and for so long as Micromet actually indemnifies Lonza pursuant to Clause 9.5 below);

 

 

(i)

the Micromet Process had been used to manufacture Product in accordance with cGMP and the Specifications; and

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  

 

21


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

    

 

(j)

Micromet will promptly notify Lonza in writing if it receives or is notified of a claim from a Third Party that the Cell Line, the Micromet Process, other Micromet Materials, the Micromet Confidential Information, Micromet Technology or that the use by Lonza thereof for the provision of the Works and Services infringes any Intellectual Property of such Third Party.

 

 

For the avoidance of doubt, Section 3.3 of the  [***]  does in no way limit the warranties given under this Clause 9.2.

 

9.3

Disclaimer:   THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, AND, EXCEPT FOR THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT, ALL OTHER WARRANTIES, BOTH EXPRESS AND IMPLIED, ARE EXPRESSLY DISCLAIMED, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

 

9.4

Indemnification by Lonza:  Subject to Clause 9.6 below, Lonza shall defend, indemnify and hold harmless each of Micromet, its Affiliates, and their directors, officers, and employees and the successors and assigns of any of the foregoing (each a " Micromet Indemnitee ") from and against any Third Party claims, actions, liabilities, costs and expenses (including court costs and legal fees on a full indemnity basis) that Micromet may suffer arising directly out of

 

 

(a)

any breach of the warranties given by Lonza in Clause 9.1 above; or

 

 

(b)

any claims alleging that Lonza’s use of the Lonza Process (i.e., claims which do not allege that the Micromet Process is infringing), the Lonza Technology and/or  [***] Intellectual Property (i.e., claims which do not allege that the use of  [***]  and/or the  [***]  is infringing) infringes any rights (including without limitation any Intellectual Property) vested in a Third Party (whether or not Lonza knows or ought to have known the same), provided that there shall be excluded from this indemnity all Micromet revenue; or

 

 

(c)

any negligent or willful act or omission of Lonza in relation to the Product.

 

9.5

Indemnification by Micromet:     Subject to Clause 9.6 below, Micromet shall defend, indemnify and hold harmless each of Lonza, its Affiliates, and their directors, officers, and employees and the successors and assigns of any of the foregoing (each a " Lonza Indemnitee ") from and against any Third Party claims, actions, liabilities, costs and expenses (including court costs and legal fees on a full indemnity basis), that Lonza may suffer arising directly out of

 

 

(a)

any breach of the warranties given by Micromet in Clause 9.2 above; or

 

 

(b)

any claims alleging Lonza’s use of the Cell Line, the Micromet Process, the Micromet Materials or the Micromet Technology infringes any rights (including, without limitation, any Intellectual Property) vested in any Third Party (whether or not Micromet knows or ought to have known about the same) provided that there shall be excluded from this indemnity all Lonza actual or potential revenues other than those which are an integral part of any Price or fees which Micromet is obliged to pay to Lonza under this Agreement; or

 

 

(c)

any negligent or wilful act or omission of Micromet in relation to the Product; or

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

22


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

   

 

(d)

any claims raised by  [***]  against Lonza under Section 3.6 (b) and/or (c) of the  [***] , and any claims resulting from an early termination of the  [***]  by  [***] , provided that Micromet is not required to indemnify Lonza of such claims under Clause 9.4 above.

 

9.6

Indemnification Procedure:  If a Lonza Indemnitee or Micromet Indemnitee (the " Indemnitee ") intends to claim indemnification under this Clause 9, it shall promptly notify the other Party (the " Indemnitor ") in writing of such alleged liability.  The Indemnitor shall have the right to control the defence thereof with counsel of its choice as long as such counsel is reasonably acceptable to Indemnitee; provided, however, that any Indemnitee shall have the right to retain its own counsel at its own expense, for any reason, including if representation of any Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other Party reasonably represented by such counsel in such proceeding.  The Indemnitee, its employees and agents, shall reasonably cooperate with the Indemnitor and its legal representatives in the investigation of any liability covered by this Clause 9.  The obligations of this Clause 9.6 shall not apply to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld or delayed unreasonably.  The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any such action, if prejudicial to its ability to defend such action, shall relieve the Indemnitor of any obligation to the Indemnitee under this Clause 9.  It is understood that only Lonza or Micromet may claim indemnity under this Clause 9 (on its own behalf or on behalf of its Indemnitees), and other Indemnitees may not directly claim indemnity hereunder.

 

9.7

Disclaimer of Consequential Damages:   Subject to the second sentence of this Clause 9.7, in no event shall either Party be liable to the other Party for incidental, indirect, special, punitive or consequential damages arising from or related to breach of this Agreement.  The foregoing disclaimer of damages shall not apply in the case of (a) breach of Clause 10 (Confidentiality), (b) personal injury or death, or (c) grossly negligent or intentionally wrongful acts or omissions.

 

9.8

Limitation of Liability:   Subject to clause 9.7 and to the second sentence of this clause 9.8, in no event shall Lonza’s liability to Micromet for direct damages arising from or related to breach of this Agreement exceed the total maximum aggregate sum payable under this Agreement by Micromet.  The foregoing limitation of liability shall not apply in the case of (a) breach of clause 10 (Confidentiality), (b) personal injury or death, or (c) negligent or intentionally wrongful acts or omissions.

 

9.9

Insurance:   Lonza and Micromet shall obtain and maintain during the term of this Agreement and for  [***]  thereafter general liability insurance with a reputable and solvent insurance provider in the amount of  [***]  per event or linked events.  Such general liability insurance shall insure against all mandatory liability including liability for personal injury, physical injury and property damage.  The Parties shall provide each other with written proof of the existence of such insurance upon request.

 

9.10

[***] :   In order to execute this Agreement, Micromet has required Lonza to enter into the  [***] .  Micromet acknowledges and agrees that Lonza has no liability to Micromet under this Agreement or otherwise, should any action or step be taken by  [***]  and/or Lonza in compliance with the  [***] .

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

23


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

   

10. 

Confidentiality

 

10.1

Micromet acknowledges that Lonza Confidential Information, and Lonza acknowledges that Micromet Confidential Information (jointly the " Confidential Information ") with which they are supplied by the other pursuant to the Agreement are supplied, subject to Clause 10.5, in circumstances imparting an obligation of confidence and each agrees to keep such Confidential Information secret and confidential and to respect the other's proprietary rights therein and not at any time for any reason whatsoever to disclose or permit such Confidential Information to be disclosed to any Third Party save as expressly provided herein.

 

10.2

Micromet and Lonza shall each procure that all their respective employees, consultants, contractors and persons for whom it is responsible having access to Lonza Confidential Information or Micromet Confidential Information shall be subject to the same obligations of confidence as the principals pursuant to Clauses 10.1 and 10.3 and shall be bound by secrecy agreements in support of such obligations.

 

10.3

Lonza and Micromet each undertake not to disclose or permit to be disclosed to any Third Party other than to those of its officers, employees, agents, consultants, licensees and financial investors that have a need to know the Confidential Information of the disclosing Party for purposes of this Agreement, provided that such disclosure will be made under a confidentiality non-disclosure agreement comprising of terms at least as stringent as the confidentiality provisions under this Clause 10.  Furthermore, Micromet will be entitled to disclose the Process and the terms and conditions of this Agreement to (i) potential licensees or collaboration partners regarding the Product, and to (ii) potential acquirers of Micromet, provided, however, that such potential licensees, collaboration partners or acquirers are in an advanced due diligence stage, that such disclosure is necessary to evaluate the respective project, that such potential licensee or collaboration partner is one of the fifty (50) leading pharmaceutical companies in the world, based on annual sales, and has its headquarters in the permitted territories listed in Schedule 12 (but may not be disclosed to Affiliates outside these permitted territories) and that such disclosure will be made under a confidentiality non-disclosure agreement comprising of terms at least as stringent as the confidentiality provisions under this Clause 10.  With respect to any other potential licensees, collaboration partners and acquirers disclosure can only be made upon Lonza's prior written consent, such consent not to be unreasonably withheld or delayed.  The Parties shall take responsibility for any infringement of confidentiality by any Third Party to which the receiving Party discloses Confidential Information of the disclosing Party.

 

10.4

Notwithstanding Clause 10.3, Lonza and Micromet each undertake not to otherwise make use of or permit to be made use of the Confidential Information of the other Party or except to the extent that the same is required to be disclosed pursuant to subpoena, court order, judicial process or otherwise by law, provided that the receiving Party provides prompt notice to the disclosing Party of such requirement in order to give the disclosing Party an opportunity to timely seek a protective order or other appropriate judicial relief.  In the event the disclosing Party is unable to obtain a protective order or other appropriate judicial relief, the receiving Party shall disclose only that portion of the disclosing Party’s Confidential Information which is legally required to be disclosed, and ensure that all such Confidential Information of the disclosing Party shall be redacted to the fullest extent permitted by law prior to such disclosure and that the disclosing Party shall be given an opportunity to review the Confidential Information prior to its disclosure.

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

24


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

   

10.5

The obligations of confidence referred to in this Clause 10 shall not extend to any information for which the receiving Party can prove by written evidence that:

 

 

(a)

it was or became generally available to the public otherwise than by reason of a breach by the receiving Party of the provisions of this Clause 10;

 

 

(b)

it was known to the receiving Party and is at its free disposal prior to its receipt from the disclosing Party;

 

 

(c)

it was subsequently disclosed to the receiving Party without being made subject to an obligation of confidence by a Third Party;

 

 

(d)

Lonza or Micromet are required to disclose under any statutory, regulatory or similar legislative requirement, subject to the imposition of obligations of secrecy wherever possible in that relation; or

 

 

(e)

it was developed by any servant or agent of the receiving Party without access to or use or knowledge of the information by the disclosing Party.

 

10.6 

The Parties acknowledges that:

 

 

(a)

without prejudice to any other rights and remedies that the Parties may have, the Parties agree that the Lonza Confidential Information and Micromet Confidential Information is valuable and that damages may not be an adequate remedy for any breach of the provisions of this Clause 10.  The Parties agree that the relevant Party will be entitled without proof of special damage to seek the remedies of an injunction and other equitable relief for any actual or threatened breach by the other Party;

 

 

(b)

save as provided herein Lonza shall not at any time have any right, title, licence or interest in or to the Micromet Technology or any other Intellectual Property vested in Micromet or to which Micromet is entitled; and

 

 

(c)

save as provided herein Micromet shall not at any time have any right, title, licence or interest in or to Lonza Confidential Information, the Lonza Technology or any other Intellectual Property relating to the Process which are vested in Lonza or to which Lonza is otherwise entitled.

 

10.7

All Confidential Information is and shall remain the sole and exclusive property of the disclosing Party.  The receiving Party agrees that upon termination of this Agreement and subject to Micromet's right to retain certain Confidential Information under the Technology Transfer and License Agreement, within  [***]  thereafter, the receiving Party shall:  (a) cease any use of the Confidential Information, including any  [***] , and all copies of the foregoing or any portion thereof, in whatever form or medium stored, and (b) transfer all Confidential Information of the disclosing Party, including all documents, samples, summaries, extracts, records or other materials that contain any Confidential Information, in whatever form or medium stored, to the disclosing Party or its designee, and such designee shall be subject to legally binding nondisclosure and use restrictions that are at least as restrictive as the terms of this Agreement, and (c) upon completion of such transfer, certify in writing that such transfer is complete.

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

25


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

     

11. 

Option for  [***]

 

11.1

Lonza hereby grants to Micromet an option to conclude a  [***]  for the  [***] .  The terms and conditions of such  [***]  shall be negotiated in good faith and based on the conditions provided in Schedule 13 .  On a regular basis during the term of this Agreement, Lonza will inform Micromet about the lead times for reservations of slots for the  [***]  and the Parties will agree on any reasonable updates to Schedule 13, such first update to be agreed after establishment of the Process at Lonza.

 

11.2

Due to the need of  [***] , Micromet will  [***] for  [***] at the latest  [***] prior to the  [***] of  [***] .  In the event that such  [***]  is not concluded before regulatory approval for the Product is granted, Micromet's option under this Clause 11 will expire.

 

12. 

Termination of the Agreement, Termination of Certain Works and Services or Slots

 

12.1

This Agreement shall commence on the Effective Date and shall expire upon completion of the Works and Services, unless earlier terminated in accordance with this Clause 12.

 

12.2

If it becomes apparent to either Lonza or Micromet at any stage in the provision of the Works and Services that it will not be possible to complete the Works and Services for scientific or technical reasons, such issue shall be discussed in the Steering Committee and a  [***]  period shall be allowed for good faith discussion and attempts to resolve such problems or to agree on a mutual termination of this Agreement. If such problems are not resolved within such period, Micromet shall be entitled to terminate the Agreement forthwith by notice in writing and with immediate effect.  Furthermore, Micromet may in its sole discretion terminate this Agreement in whole or terminate certain Works and Services or production slots of the Project Plan at any time for any reason by giving not less than  [***]  notice in writing to Lonza.  In the event of any such termination outlined above, Micromet shall pay to Lonza a termination sum calculated by reference to all the Works and Services performed by Lonza prior to such termination (including a pro rata proportion of the Price for any stage of the Works and Services which is in process at the date of termination) and all expenses reasonably incurred by Lonza in giving effect to such termination, including the costs of terminating any commitments entered into under the Agreement, provided, however, that Lonza will make all reasonable efforts to use any materials and services intended for Micromet for other purposes.  The termination sum shall not exceed the unpaid Price for the stage in process and any prior stages and no re-imbursement to Lonza is owed by Micromet in the event notice to terminate Works and Services pursuant to this Clause 12.2 is issued to Lonza more than  [***]  before Lonza's then estimated start date for any stage.

 

12.3

In the event of termination pursuant to Clause 12.2 and subject to Clauses 12.5, 12.6 and 12.7 Micromet shall pay Lonza a termination sum regarding terminated production slots calculated in accordance with the principles of Clause 12.2 above plus:

 

 

(a)

in the event notice to terminate Works and Services pursuant to this Clause 12.3 is issued to Lonza  [***]  or less before Lonza’s then estimated start date for any stage of those Works and Services which include activities in Lonza’s cGMP fermentation and/or purification facilities (i.e., the cGMP Batches), or is issued to Lonza at any time during any such stage, Micromet shall pay Lonza a sum equal to  [***]   [***] , which payment to Lonza shall become due on the date of termination of such Works and Services; or

   

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

26


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

     

 

(b)

in the event notice to terminate Works and Services pursuant to this Clause 12.3 is issued to Lonza more than  [***]  but not more than  [***]  before Lonza’s then estimated start date for any stage of those Works and Services which include activities in Lonza’s cGMP fermentation and/or purification facilities (i.e. the cGMP Batches), Micromet shall pay Lonza a sum equal to  [***]   [***] ; which payment to Lonza shall become due on the date of termination of such Works and Services; or

 

 

(c)

in the event notice to terminate Works and Services pursuant to this Clause 12.3 is issued to Lonza more than  [***]  but not more than  [***]  months before Lonza’s then estimated start date for any stage of those Works and Services which include activities in Lonza’s cGMP fermentation and/or purification facilities (i.e. the cGMP Batches), Micromet shall pay Lonza a sum equal to  [***]   [***] ; which payment to Lonza shall become due on the date of termination of such Works and Services.

 

 

The price of the  [***]  shall not include the  [***] .  Any  [***]  ordered at the time of termination which cannot be used by Lonza for other purposes will be paid by Micromet and Micromet may request transfer of such  [***]  to Micromet.

 

 

No re-imbursement to Lonza is owed by Micromet in the event notice to terminate Works and Services pursuant to this Clause 12.3 is issued to Lonza more than  [***]  months before Lonza's then estimated start date for any Batch.  Furthermore and for the avoidance of doubt, no re-imbursement to Lonza is owed by Micromet in the event a  [***] is  [***] but has to  [***] to  [***] to a  [***] in the  [***] of the  [***] , unless such  [***] is subsequently  [***]

 

12.4

Lonza shall use commercially reasonable efforts to otherwise use any capacities and  [***] fully or partly, which have been  [***] for  [***] and which are  [***] to the  [***] of certain  [***] and  [***] or the  [***]   The obligation to make payment under Clause12.3 shall be reduced (retrospectively, and hence Lonza shall make an appropriate refund to Micromet) to the extent that Lonza mitigates its loss in this regard (and Lonza shall promptly notify Micromet of any such mitigation).  This provision shall not entitle Micromet to be refunded an amount greater than that paid by Micromet to Lonza pursuant to this Clause 12 and Lonza shall be entitled to deduct from the amount due to be refunded to Micromet its reasonable personnel and associated costs in attempting to mitigate its loss.

 

12.5

For the avoidance of doubt activities relating to cGMP fermentation shall be deemed to commence with the date of removal of the vial of cells from frozen storage for the performance of the fermentation.

 

12.6

The Parties may each terminate the Agreement forthwith by notice in writing to the other Party if the other commits a material breach of the Agreement (which shall include a breach of the warranties set out in Clause 9 above) which in the case of a breach capable of remedy is not remedied within  [***]  in the event of a breach of payment obligations, and within  [***]  in the event of any other breach, of the receipt by the other of notice identifying the breach and requiring its remedy.

 

12.7

Micromet may terminate this Agreement forthwith by notice in writing to Lonza upon the occurrence of any of the following events:

 

 

(a)

Lonza is unable  [***] set forth in  [***] and incurs  [***] for reasons other than  [***] the  [***] and/or the  [***] or  [***] in accordance with this Agreement; or

 [***] (b)

the use of  [***] for the manufacture of Product [***] provided, however, that   [***] pay the termination fees under Clauses 12.2 and 12.3 above if at  [***] that the [***] ; or [***] (c)

Lonza  [***] or  [***] of the  [***] or  [***] .

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

27


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

     

12.8 

Upon the termination of this Agreement for whatever reason:

 

 

(a)

Lonza shall promptly return to Micromet all Micromet Know How and shall dispose of or return to Micromet the Micromet Materials, the Micromet Cell Line and the Micromet Process and any materials therefrom, as directed by Micromet;

 

 

(b)

Micromet shall promptly return to Lonza all Lonza Confidential Information it has received from Lonza;

 

 

(c)

Lonza shall summarize all Works and Services performed up to the termination of the Agreement and provide such summary documents to Micromet;

 

 

(d)

subject to Clause 14 below, Micromet shall not thereafter use or exploit the Lonza Technology in any way whatsoever; and

 

 

(e)

Lonza and Micromet shall do all such acts and things and shall sign and execute all such deeds and documents as the other may reasonably require to evidence compliance with this Clause 12.8.

 

12.9

Termination of this Agreement for whatever reason shall not affect the accrued rights of either Lonza or Micromet arising under or out of this Agreement and all provisions which are expressed to survive the Agreement shall remain in full force and effect.

 

13. 

[***]

 

Lonza agrees that for so long as  [***]  of the  [***]  for the  [***]  or  [***] , it shall not, directly or indirectly:

 

 

(a)

engage in, continue in or carry on [***] any  [***] of  [***] which contain the same  [***]  as the  [***]  or  [***] , including  [***] any  [***] in any  [***]  or other form of  [***]  which is so engaged;

 

 

(b)

consult with, advise or assist in any way, whether or not for consideration, any corporation or other business organization which  [***] or  [***] containing the same  [***]  as the  [***]  or  [***] ;

 

 

(c)

engage in any practice the purpose of which is to evade the provisions of this  [***] ;

 

 

provided, however, that the foregoing prohibition does not extend to  [***]  of the  [***]  of the  [***] .

 

14. 

Technology Transfer and License

 

 

At any time during the course of this Agreement and  [***] (except in the case of  [***] , Micromet has the option to conclude the Technology Transfer and License Agreement between Micromet and Lonza attached hereto as Schedule 14 , in order to allow Micromet (or a Third Party designated by Micromet) to replicate the Process (as it exists at the date of such request) in the manufacture of the Product in order to either establish a second source for supply or to transfer manufacturing to a Third Party, provided, however, that if Micromet is or has been in insolvency proceedings at the time Micromet [***] under this Clause 14, it shall  [***] if  [***] by  [***] and/or other  [***] which are  [***] and operating, with respect of the  [***]  of the  [***] (but not by  [***] ,  [***] and/or other  [***] ).  Following exercise of the option and provided  [***]  of Lonza have been used for the manufacture of Product, Lonza shall supply to Micromet such information and assist Micromet regarding access to  [***] and  [***] , as is agreed therein.

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

28


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

    

15. 

Force Majeure

 

15.1

If Lonza is prevented or delayed in the performance of any of its obligations under the Agreement by Force Majeure and shall give written notice thereof to Micromet specifying the matters constituting Force Majeure together with such evidence as Lonza reasonably can give and specifying the period for which it is estimated that such prevention or delay will continue, Lonza shall be excused from the performance or the punctual performance of such obligations as the case may be from the date of such notice for so long as such cause of prevention or delay shall continue.

 

15.2

The expression " Force Majeure " shall be deemed to include any cause affecting the performance by Lonza of the Agreement arising from or attributable to acts, events, acts of God, omissions or accidents beyond the reasonable control of Lonza.

 

16. 

Governing Law, Jurisdiction and Enforceability

 

16.1

The construction, validity and performance of the Agreement shall be governed by the laws of Switzerland.

 

16.2

No failure or delay on the part of either Lonza or Micromet to exercise or enforce any rights conferred on it by the Agreement shall be construed or operate as a waiver thereof nor shall any single or partial exercise of any right, power or privilege or further exercise thereof operate so as to bar the exercise or enforcement thereof at any time or times thereafter.

 

16.3

Any disputes relating to issues arising from this Agreement shall, in the absence of resolution within  [***]  of the dispute arising, be referred to the  [***]  of Micromet and Lonza, who shall discuss the matter and attempt to resolve it by mutual consent.  The  [***]  of Micromet and Lonza shall meet once face-to-face within  [***]  to discuss and resolve the dispute.  If the dispute cannot be resolved within  [***] , either Party may, by written notice to the other Party, invoke the mediation procedure set out in Clause 16.4 below.

 

16.4

If a dispute arises between the Parties that the Parties cannot resolve pursuant to Clause 16.3 above, the Parties agree to try to solve such dispute amicably by mediation.  The Parties shall conduct a mediation procedure according to the ICC ADR Rules of the International Chamber of Commerce (ICC) in effect on the date of the commencement of the mediation proceedings.  The location of the mediation proceedings will be Basel. The number of mediators will be one (1).  The language of the mediation proceeding will be English.  If the dispute has not been settled pursuant to the said rules within  [***]  following the filing of a request for mediation or within such other period as the Parties may agree in writing, either Party may submit the dispute to final and binding arbitration.

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
   

 

29


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

    

16.5

Any dispute relating to the validity, performance, construction or interpretation of this Agreement, which cannot be resolved amicably between the Parties, shall be submitted to arbitration in accordance with the ICC Arbitration Rules of the International Chamber of Commerce.  The decision of the arbitrators shall be final and binding upon the Parties (absent manifest error on the part of the arbitrator(s)) and enforceable in any court of competent jurisdiction.  The location of arbitration will be Basel.  The arbitration will be heard and determined by one (1) arbitrator, who will be jointly selected by Lonza and Micromet.  If, within  [***]  following the date upon which a claim is received by the respondent, the Parties cannot agree on a single arbitrator, the arbitration will be heard and determined by three (3) arbitrators, with one arbitrator being appointed by each Party and the third arbitrator being selected by the two Party-appointed arbitrators.  If either Party fails to select an arbitrator, or if the Party-appointed arbitrators cannot agree on a third arbitrator within  [***]  of the respondent receiving the claim, such arbitrator will be appointed by the International Court of Arbitration according to the ICC Rules.  The arbitration award that is consistent with the provisions of this Agreement that is so given will be binding upon the Parties, accompanied by a reasoned opinion in writing (in English), and the judgment on the award may be entered in any court having competent jurisdiction thereof.  Each Party will bear its own costs and expenses (including its attorney’s fees) associated with any arbitration initiated under this section, and each Party will bear an equal share of the arbitrators’ and administrative fees associated with any arbitration initiated under this section.  The language of the arbitration proceeding will be English.  Notwithstanding the provisions of this Clause 16.5, each Party shall have the right to seek preliminary or permanent injunctive or other equitable relief in any court of competent jurisdiction as such Party deems necessary to preserve its rights and to protect its interests.

 

16.6

Nothing in this Clause 16 shall prevent a Party from exercising any right under this Agreement, including the right of termination under Clause 12 above.

 

17. 

Notices

 

17.1

Any notice or other communication to be given under this Agreement shall be delivered personally or sent by facsimile transmission, or if facsimile transmission is not available, by first class pre-paid post addressed as follows:

 

(a)

If to Lonza to:

Lonza Sales AG

 

 

Muenchensteinerstrasse 38

 

 

CH-4402 Basel

 

 

Switzerland

 

 

Facsimile: +41 61 316 8329

 

 

Attention: The Head of Legal Services

 

 

 

 

with a copy to:

Lonza Biologics plc

 

 

228 Bath Road

 

 

Slough

 

 

Berkshire SL1 4DX

 

 

England

 

 

Facsimile: +44 1753 777001

 

 

Attention:  The Head of Legal Services

   

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
   

 

30


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

    

(b)

If to Micromet to:

Micromet AG

 

 

Staffelseestrasse 2

 

 

D-81477 Munich

 

 

Germany

 

 

Facsimile: +49-89-895 277 205

 

 

Attention: Head of Business Development

 

 

 

 

with a copy to:

Micromet, Inc.

 

 

6707 Democracy Boulevard

 

 

Suite 505

 

 

Bethesda, MD 20817

 

 

United States of America

 

 

Attention: General Counsel

 

 

Facsimile: +1 240 752-1425

 

or to such other destination as either Party hereto may hereafter notify to the other in accordance with the provisions of this Clause 17.

 

17.2 

All such notices or other communications shall be deemed to have been served as follows:

 

 

(a)

if delivered personally, at the time of such delivery;

 

 

(b)

if sent by facsimile, upon receipt of the transmission confirmation slip showing completion of the transmission;

 

 

(c)

if sent by first class pre-paid post, ten (10) business days (Saturdays, Sundays and Bank or other public holidays excluded) after being placed in the post.

 

18. 

Illegality

 

18.1

If any provision or term of this Agreement or any part thereof shall become or be declared illegal, invalid or unenforceable for any reason whatsoever including but without limitation by reason of the provisions of any legislation or other provisions having the force of law or by reason of any decision of any Court or other body or authority having jurisdiction over the Parties hereto or this Agreement including the EC Commission or the European Court of Justice:

 

 

(a)

such provision shall, so far as it is illegal, invalid or unenforceable, be given no effect by the Parties and shall be deemed not to be included in this Agreement;

 

 

(b)

the other provisions of this Agreement shall be binding on the Parties as if such provision was not included therein; and

 

 

(c)

the Parties agree to negotiate in good faith to amend such provision to the extent possible for incorporation herein in such reasonable manner as most closely achieves the intention of the Parties without rending such provision invalid or unenforceable.

 

19. 

Quality Agreement

 

 

Simultaneously with the execution of this Agreement, the Parties will enter into a separate quality agreement as annexed hereto as Schedule 10 (" Quality Agreement ").  The Quality Agreement and its Exhibits supplement this Agreement.  To the extent that inconsistencies exist between the contents of the Quality Agreement and this Agreement, the stipulations of this Agreement shall prevail.

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

31


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

    

20. 

Miscellaneous

 

20.1

Lonza shall be entitled to instruct one or more of its Affiliates to perform any of Lonza’s obligations contained in this Agreement, but Lonza shall remain fully responsible in respect of those obligations.  Subject thereto, neither Party shall be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement without the prior written consent of the other which consent shall not be unreasonably withheld or delayed, save that either Party shall be entitled without the prior written consent of the other Party to assign, transfer, charge, sub-contract, deal with or in any other manner make over the benefit and/or burden of this Agreement to a successor of that Party’s business by reason of merger, sale or license of all or substantially all of its assets related to this Agreement or any other form of acquisition.

 

20.2

The obligations of the Parties under Clauses 8 (Intellectual Property), 9 (Warranties and Indemnification), 10 (Confidentiality), and 12.8 and 12.9 (consequences of termination) and 14 (Technology Transfer and License) shall survive the termination of this Agreement for any reason.

 

20.3

The press releases that Micromet and Lonza will issue upon execution of this Agreement are attached hereto as Schedule 15 .  The text of any further press release or other further communication to be published by or in the media concerning the subject matter of the Agreement shall require the prior written approval of Lonza and Micromet.

 

20.4

The Agreement embodies the entire understanding of Lonza and Micromet and there are no promises, terms, conditions or obligations, oral or written, expressed on implied, other than those contained in the Agreement.  The terms of the Agreement shall supersede all previous agreements (if any) which may exist or have existed between Lonza and Micromet relating to the Works and Services.

 

20.5

The Parties to this Agreement do not intend that any term hereof should be enforceable by any person who is not a Party to this Agreement.

 

20.6

No variation of or addition to this Agreement or any part thereof shall be effective unless in writing and signed on behalf of both Parties.  Notwithstanding the above the Parties hereby confirm that amendments to the Specifications shall be effective if reduced to writing and signed by the quality and/or regulatory representative of both Parties, which quality and/or regulatory representative shall be nominated from time to time by each Party.

 

List of Schedules:

 

Schedule 1:

 

Micromet Materials including Cell Line Particulars

Schedule 2:

 

Product Specifications

Schedule 3:

 

Prices and Terms of Payment

Schedule 4:

 

Identification of Lonza Know How

Schedule 5:

 

List of Lonza Patent Rights

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

   

 

32


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

    

       

Schedule 6:

 

Identification of Micromet Know-How

Schedule 7:

 

List of Micromet Patent Rights

Schedule 8 A:

 

Project Plan up to Stage 30

Schedule 8 B:

 

Project Plan for pre-LA (as of Stage 31)

Schedule 9:

 

 [***]  Agreement

Schedule 10:

 

Quality Agreement

Schedule 11:

 

Testing of Product

Schedule 12:

 

Territories

Schedule 13:

 

Terms and Conditions for  [***]

Schedule 14:

 

Technology Transfer and License Agreement

Schedule 15:

 

Micromet Press Release and Lonza Press Release

 

AS WITNESS the hands of the duly authorised representatives of the Parties hereto the day and year first above written.

 

Micromet AG

 

Lonza Sales AG

 

 

 

 

 

Signature:

/s/ Jens Hennecke

 

Signature:

/s/ Una Hultry

Printed Name:

Jens Hennecke

 

Printed Name:

Una Hultry

Title:

SVP Business Development

 

Title:

Authorized Signatory

 

 

 

 

 

Signature:

/s/ Patrick Baeuerle

 

Signature:

/s/ Gerry Kennedy

Printed Name:

Patrick Baeuerle

 

Printed Name:

Gerry Kennedy

Title:

SVP, Chief Scientific Officer

 

Title:

Authorized Signatory

   

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 

33


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

     

SCHEDULE 1

 

Micromet Materials including Cell Line Particulars

 

[***]

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

  

SCHEDULE 2

 

Product Specifications

[***]

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 


 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
  

SCHEDULE 3

 

Price and Terms of Payment


 

[***]

   

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
    

SCHEDULE 4

 

Identification of Lonza Know How

(to be licensed to Micromet under Schedule 14)

 

[***]

 

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
 

 


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
    

SCHEDULE 5

 

List of Lonza Patent Rights


 

[***]

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
   

SCHEDULE 6

 

Identification of Micromet Know-How

 

 

[***]

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
    

SCHEDULE 7

 

List of Micromet Patent Rights

 

Application

Number

 

Application

Filing Date

 

 

Country

 

 

Title of Application

 

 

Status

 

 

Patent Number

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[***]

   

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

  

 


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
   

SCHEDULE 8 A

 

Project Plan

 

[***]

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

   

 


 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
  

SCHEDULE 8 B

 

Project Plan for pre-LA (as of Stage 31)

  

[***]

  

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
  

 


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2
   

SCHEDULE 9

 

[***]  Agreement

[***]

    

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
   

 


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

 

SCHEDULE 10

 

TO THE DEVELOPMENT AND SUPPLY AGREEMENT

Dated November 23, 2009

 

LONZA SALES AG

 

AND

 

MICROMET AG

 


 

QUALITY AGREEMENT

 


 

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2

Schedule 10

 

THIS QUALITY AGREEMENT is made

 

BETWEEN

 

1.

LONZA SALES AG , of Muenchensteinerstrasse 38, CH-4002, Basel, Switzerland (hereinafter referred to as " Lonza ") and

 

2.

MICROMET AG , of Staffelstrasse 2, D-81477, Munich, Germany (hereinafter referred to as " Micromet ")

 

WHEREAS:

 

A

Lonza and Micromet have entered into a Development and Supply Agreement pursuant to which Lonza agreed to provide Micromet with development, manufacturing and supply services (" Works and Services ") for Micromet's Intermediate Biological (Investigational) Medicinal Product (IB(I)MP) MT103 (also known as Blinatumomab) for use as proprietary investigational medicinal product (the " Product ").

 

B.

The Parties now wish to further define the pharmaceutical roles and responsibilities of each Party for the Manufacture, testing and Release of Product with respect to relevant current Good Manufacturing Practices (" cGMP ") and Applicable Laws. Nothing in this Quality Agreement shall limit a Party’s obligation to comply with cGMP and Applicable Laws (as defined below) on the occasion that Lonza Manufactures Product for Micromet for further manufacturing use in the preparation of human drug products for clinical trial supply.

 

C

This Quality Agreement takes the form of a detailed checklist of the activities associated with the production, analysis, release, and distribution of Product. Responsibility for each activity is assigned to either Lonza and/or Micromet in the appropriate box in the delegation responsibility checklist that follows. To facilitate routine communications between the Parties, a list of key contacts is provided in Annex 1 . For each responsibility listed, the respective Party is required to put into effect all applicable procedures and to take all necessary actions to execute that responsibility in accordance with cGMP and Applicable Laws.

 

D.

The Parties wish that Lonza, having particular expertise in the activities contained in this Quality Agreement (as defined below), may perform the activities and obligations set forth in this Quality Agreement.

 

*** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

2


 

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. �


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