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SEC filings
20-F
BIOLINERX LTD. filed this Form 20-F on 03/10/2016
Entire Document
 
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3.3          Debarred Personnel; Exclusion Lists.  A Party shall not employ or subcontract with any Person or Third Party that is excluded, debarred, suspended, proposed for suspension or debarment, in Violation or otherwise ineligible for government programs for the performance of the Study or any other activities under this Agreement or the Related Agreements.  Each Party hereby certifies that it has not employed or otherwise used in any capacity and will not employ or otherwise use in any capacity, the services of any Person suspended, proposed for debarment, or debarred under United States law, including 21 USC 335a, or any foreign equivalent thereof, in performing any portion of the Study or other activities under this Agreement or the Related Agreements and that such Party has, as of the Effective Date, screened itself, and its officers and directors, against the Exclusions Lists and that it has informed the other Party in writing whether it or any of its officers or directors has been in Violation.  A Party shall notify the other Party in writing immediately if any such suspension, proposed debarment, debarment or Violation occurs or comes to its attention, and shall, with respect to any Person so suspended, proposed for debarment, debarred or in Violation, promptly remove such Person from performing activities, function or capacity related to the Study or otherwise related to activities under this Agreement or the Related Agreements.
 
3.4          Regulatory Matters.  BioLineRx shall ensure that all Regulatory Approvals from any Regulatory Authority, ethics committees and/or institutional review boards with jurisdiction over the Study are obtained prior to initiating performance of the Study.  Merck shall have the right (but no obligation) to participate in any discussions with a Regulatory Authority regarding matters related to the Merck Compound.  Each Party shall provide to the other, as necessary, a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate the Right of Reference.  Notwithstanding anything to the contrary in this Agreement, neither Party shall have any right to access the other Party’s CMC data with respect to its Compound.  Merck shall authorize FDA and other applicable Regulatory Authorities to cross-reference the appropriate Merck Compound INDs and CTAs to provide data access to BioLineRx sufficient to support conduct of the Study.  If Merck’s CTA is not available in a given country, Merck will file its CMC data with the Regulatory Authority for such country, referencing BioLineRx’s CTA as appropriate (however, BioLineRx shall have no right to directly access the CMC data).
 
3.5          Documentation.  Each Party shall maintain reports and all related documentation in good scientific manner and in compliance with Applicable Law.  Each Party shall provide to the other Party Study information and documentation reasonably requested by the other Party to enable the other Party to (i) comply with any of its legal, regulatory and/or contractual obligations, or any request by any Regulatory Authority, related to the such other Party’s Compound, and (ii) in the case of Merck, to determine whether the Study has been performed in accordance with this Agreement.
 
3.6          Copies. BioLineRx shall provide to Merck copies of all Clinical Data, in electronic form or other mutually agreeable alternate form and on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines [*].  BioLineRx shall ensure that all patient authorizations and consents required under HIPAA, the EU Data Protection Directive or any other similar Applicable Law in connection with the Study permit such sharing of Clinical Data with Merck.