Agreement Effective Date Merck BioLineRx Party Parties
    
  
  
  
    1  Definitions
  Article 1
  1.1 Affiliate Section 1.1 control
  1.2 Agreement
  
 1.3 Alliance Manager Section 3.10
  1.4 Applicable Law FDA EMA Regulatory Authority Regulatory Authorities HIPAA
  1.5 BioLineRx
  1.6
  1.7 BioLineRx Class Compound
  1.8 BioLineRx Compound
  1.9 BioLineRx Inventions Section 10.2
  1.10 Business Day
  1.11 cGMP
  1.12 Clinical Data
  1.13 Clinical Quality Agreement Section 8.2
  1.14 CMC
  
 1.15 Compounds Compound
  1.16 Combination
  1.17 Confidential Information Receiving Party Disclosing Party
  1.18 Continuing Party Section 10.1.3
  1.19 Control Controlled
  1.20 CTA
  1.21 Data Sharing and Sample Testing Schedule Schedule I
  1.22 Defending Party Section 14.2.3
  1.23 Delivery Section 8.4.1
  1.24 Direct Manufacturing Costs Section 6.12
  1.25 Disposition Package Section 8.8.1
  1.26 Dispute Section 22.1
  1.27 Effective Date
  1.28 EMA
  1.29 Exclusion List
  1.30 FDA
  1.31 Filing Party Section 10.1.3
  
 1.32 Force Majeure Section 16
  1.33 GAAP Section 6.12.
  1.34 GCP
  1.35 Government Official
  1.36 HIPAA
  1.37 IND
  1.38 Indirect Manufacturing Costs Section 6.12
  1.39 Inventions Section 3.14
  1.40 Joint Development Committee JDC Section 3.10
  1.41 Joint Patent Application Section 10.1.3
  1.42 Joint Patent
  1.43 Jointly Owned Invention Section 10.1.1
  1.44 Know-How
  
 1.45 Liability Section 14.2.1
  1.46 Manufacture Manufactured Manufacturing
  1.47 Manufacturer’s Release Release
  1.48 Manufacturing Costs Section 6.12
  1.49 Manufacturing Site Section 8.7
  1.50 Merck
  1.51
  1.52 Merck Compound
  1.53 Merck Inventions Section 10.3
  1.54 NDA
  1.55 Non-Conformance Section 2.3
  1.56 Non- Filing Party Section 10.1.3
  1.57 Opting-out Party Section 10.1.3
  1.58 Other Party Section 14.2.3
  1.59 Party/Parties
  1.60 PD-1 Antagonist
  1.61 Permitted Use Section 3.7
  1.62 Person
  
 1.63 Pharmacovigilance Agreement Section 5.1
  1.64 Project Manager Section 3.10
  1.65 Protocol to be finalized and agreed upon within sixty (60) calendar days after the Effective Date pursuant to Section 4.1
  1.66 Regulatory Approvals
  1.67 Regulatory Documentation
  1.68 Regulatory Authorities
  1.69 Related Agreements
  1.70 Right of Reference
  1.71 SAEs Section 5.1
  1.72 SADRs Section 5.1
  1.73 Samples
  1.74 Sample Testing
  
 1.75 Sample Testing Results
  1.76 Specifications
  1.77 Study
  1.78 Study Completion Section 3.11
  1.79 Subcontractors Section 2.4
  1.80 Term Section 6.1
  1.81 Territory
  1.82 Third Party
  1.83 VAT Section 8.16
  1.84 Violation Exclusions Lists
  2
Scope of the Agreement.
  2.1 Generally Article 7
  2.2 Obligations
  2.3 Compound Commitments Article 8 Article 8 Section 3.4
  
 2.4 Subcontracting Subcontractors
  2.5 Compounds . Section 3.14
  2.6 Relationship . Sections Section 2.6
  3
Conduct of the Study.
  3.1 Sponsor Section 3.4
  3.2 Performance
  
 3.3 Debarred Personnel; Exclusion Lists
  3.4 Regulatory Matters
  3.5 Documentation
  3.6 Copies
  
 3.7 Samples Section 3.7 Section 3.7 Permitted Use
  3.8 Ownership and Use of Clinical Data . Section 3.8 Section 12.2
  
 3.9 Regulatory Submission
  3.10 Joint Development Committee Joint Development Committee JDC Project Manager Alliance Manager
  3.11 Final Study Report Final Study Report Study Completion
  3.12
  3.13
  3.14 A mendment to Agreement; Study Option
  
 4
Protocol and Related Documents.
  4.1 Protocol within days after Appendix A
  4.1.1
        4.2 Informed Consent
  5
Adverse Event Reporting.
  5.1 Pharmacovigilance Agreement SADRs SAEs
  5.1.1
  5.1.2
  
   6
Term and Termination.
  6.1 Term three (3) months, Article 6 Term
  6.2 Merck Termination Right for Safety or for OCS Non-Consent .  Merck shall have the unilateral right to terminate this Agreement pursuant to Section 10.1.1. the Merck five (5) .  During such five (5)
  6.3 Material Breach thirty (30) days thirty (30) days, the notifying Party shall state such belief in its written breach notice, and if the breaching Party does not dispute such belief, thirty (30) day
  6.4 Mutual Termination Right for Patient Safety
  
 6.5 Mutual Termination Right Due to Regulatory Action; Other Reasons five (5) . shall have the right to terminate this upon five (5) written notice to the other Party in the event that it determines in its sole discretion to withdraw any applicable Regulatory Approval for its Compound or to discontinue development of its Compound, for medical, scientific or legal reasons.
  6.6 [Deleted]
  6.7 Return of Merck Compound Notwithstanding anything to the contrary in the foregoing, if this Agreement is terminated (a) due to patient safety or regulatory issues, the Parties will share the costs incurred by BioLineRx for such return or destruction of the Merck Compound, or (b) due to an uncured material breach by a breaching Party, then the breaching Party shall be solely responsible for the costs incurred by BioLineRx for such return or destruction of the Merck Compound.
  6.8 Anti-Corruption Section 13.4 Section 13.4 Section 6.8
  6.9 Survival Section 6.9 Sections 3.4 3.9 5.1 6.6 8.11 12.2 14.2 14.3 Articles 1 9 10 11 20 21 23 24 25 26
  6.10 No Prejudice
  6.11 Confidential Information Section 6.11
  6.12 Merck’s Manufacturing Costs Section 6.2 or 6.3 above, the Direct Manufacturing Costs and Indirect Manufacturing Costs (as defined herein) “ Direct Manufacturing Costs ” shall be calculated consistent with Generally Accepted Accounting Principles (“ GAAP ”) and include manufacturing fees; raw materials; direct labor; freight and duty, and factory overhead costs that can be directly attributed to the Compound, including but not limited to equipment maintenance and repair, supplies, ongoing stability program costs, other plant services, indirect labor and depreciation on direct capital assets.  “ Indirect Manufacturing Costs ” shall be calculated consistent with GAAP and include allocations of indirect factory overhead and site support costs, including but not limited to utilities, quality, planning, engineering, maintenance, safety, site science and technology, and depreciation on indirect capital assets, procurement, warehousing, and corporate services.  Allocations shall be based on each compound’s utilization relative to a manufacturing site’s total activity.
  6.13 BioLineRx’s Study Costs; Unused Samples . Provided the Parties do not otherwise dispute the circumstances of termination, in the event of termination by BioLine pursuant to Section  6.3 above, BioLineRx shall be entitled to (a) reimbursement by Merck for the cost of replacing Merck Compound in the Study; and (b) require Merck to destroy or, at Merck’s discretion, return to BioLineRx any unused Samples provided by BioLineRx to Merck.
 
 7
Costs of Study.
  Article 8 Article 8
  8
Supply and Use of the Compounds.
  8.1 Supply of the Compounds Section 8.1
  8.2 C linical Quality Agreement Clinical Quality Agreement
  8.3 Minimum Shelf Life Requirements
  8.4 Provision of Compounds.
  Delivery Section 8.5
  
 Delivery
  8.5 Labeling and Packaging; Use, Handling and Storage.
      8.6 Product Specifications
  8.7 Changes to Manufacturing
  8.8 Product Testing; Noncompliance
  After Manufacturer’s Release. Disposition Package
  
  8.8.2 Non-Conformance.
  Section 8.8.1 Section 8.9 Investigations Section 8.8.3
      Resolution of Discrepancies
  8.9 Investigations
  8.10 Shortage; Allocation
  
 8.11 Records; Audit Rights
  8.12 Quality
  8.13 Quality Control
  8.14 Audits and Inspections
  8.15 Recalls
  8.16 VAT VAT
  9
Confidentiality.
  Confidential Information Section 13.4.8
  
 Inventions Articles 10 11 12 Articles 10 11 12
  Personal Identifiable Data
  10
Intellectual Property.
  Joint Ownership and Prosecution
  10.1.1 Section 10.2 Section 10.3 Jointly Owned Invention Joint Rights Agreement OCS
  10.1.2
  a.
  b.
  c.
  d. subsection (d) subsection (d)
  
 10.1.3 Joint Patent Application Filing Party Non-Filing Party Opting-out Party Continuing Party
  10.1.4 Section 10.1.3 Section 9.1
  Inventions Owned by BioLineRx Section 10.1 BioLineRx Inventions
  Inventions Owned by Merck Section 10.1 Merck Inventions
    
  11 Reprints; Rights of Cross-Reference.
    12 Publications; Press Releases.
  Clinical Trial Registry www.clinicaltrials.gov
  Publication
  12.2.1
  12.2.2 Section 12.2.1
  12.2.3
  12.2.4 Section 12.2
  Press Releases Appendix C Section 12.3
  13 Representations and Warranties; Disclaimers.
    
 Compounds
  13.2.1 BioLineRx Compound
  13.2.2 M erck Compound .
  Results
  Anti-Corruption
  13.4.1
  13.4.2
  13.4.3
  13.4.4
  13.4.5 e.g.
  
 13.4.6 Section 13.4
  13.4.7
  13.4.8 Section 13.4
  13.4.9 Section 13.4 Section 13.4
  
 13.4.10 Section 13.4 Section 6.8
  DISCLAIMER
  14 Insurance; Indemnification; Limitation of Liability.
  Insurance
  Indemnification
  14.2.1 Indemnification by BioLineRx Liability
  14.2.2 Indemnification by Merck
  14.2.3 Procedure Section 14.2 Defending Party Other Party
  
 14.2.4 Study Subjects
  LIMITATION OF LIABILITY
  15
Use of Name.
    16
Force Majeure.
  e.g. Force Majeure
  17
Entire Agreement; Modification.
    
 18
[*]
  Invalid Provision
    20
No Additional Obligations.
    21
Governing Law
    22
Dispute Resolution.
  Negotiation Dispute Senior Executives
    
  23 Notices.
           
  
    
         
  
 Merck Sharp & Dohme Corp.

One Merck Drive

P.O Box 100

Whitehouse Station, NJ 08889-0100

Attention:  Office of Secretary

Facsimile No.:  [*]
  24
Relationship of the Parties.
    25
Counterparts andDue Execution.
    
 26
Construction.
     
 
                 Name
   
 
  
  
  
 
  
  
  
 
  
   
 
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  at 10:00 am EST to further discuss this immunotherapy collaboration
  , xx ®
  
  
 “Today, there is a great opportunity and need to bring forward new scientific breakthroughs for the treatment of pancreatic cancer,” said Dr. Eric Rubin, vice president and therapeutic area head, oncology early-stage development, MSD Research Laboratories. “Evaluating the potential of combination therapies through strategic collaborations in difficult-to-treat tumor types continues to be an important part of our immuno-oncology clinical development program for KEYTRUDA.”
 
 xx xx