BIOLINERX     Print Page  Close Window

SEC filings
20-F
BIOLINERX LTD. filed this Form 20-F on 03/10/2016
Entire Document
 
11

 
4
Protocol and Related Documents.
 
4.1          Protocol. A summary of the initial Protocol will be finalized and agreed upon by the Parties within [*] days after the Effective Date, using the most recent draft discussed between the Parties attached hereto as Appendix A.  BioLineRx shall provide a draft of the Protocol (and any subsequent revisions thereof) to Merck for Merck’s review and comment, consistent with the remaining provisions of this Section 4.1.
 
4.1.1       Notwithstanding the provisions of Section 4.1, each Party shall have the following decision rights:
 
a)           BioLineRx shall have the final decision-making authority with respect to the contents of the Protocol, provided that any material changes to any draft of the Protocol (other than relating solely to the BioLineRx Compound) from the draft of the Protocol previously provided to Merck, any material changes (other than relating solely to the BioLineRx Compound) to the approved final Protocol, and [*], shall require Merck’s prior written consent.  Any such proposed changes will be sent in writing to Merck’s Project Manager and Merck’s Alliance Manager.  Merck will provide such consent, or a written explanation for why such consent is being withheld, within [*] Business Days of receiving a copy of BioLineRx’s requested changes.
 
b)           [*]
 
c)           [*]
 
4.2           Informed Consent.  BioLineRx shall prepare the patient informed consent form for the Study (which shall include provisions regarding the use of Samples in Sample Testing) in consultation with Merck (it being understood and agreed that the portion of the informed consent form relating to the Sample Testing of the Merck Compound shall be provided to BioLineRx by Merck).  Any proposed changes to such form that relate to the Merck Compound, including Sample Testing of the Merck Compound, shall be subject to Merck’s review and written consent.  Any such proposed changes will be sent in writing to Merck’s Project Manager and Merck’s Alliance Manager. Merck will provide such consent, or a written explanation for why such consent is being withheld, within [*] Business Days of receiving a copy of BioLineRx’s requested changes.
 
5
Adverse Event Reporting.
 
5.1          BioLineRx will be solely responsible for compliance with all Applicable Law pertaining to safety reporting for the Study and related activities.  The Parties will use their reasonable efforts to execute a pharmacovigilance agreement (“Pharmacovigilance Agreement”) within [*] days of the Effective Date, and in any event prior to the initiation of clinical activities under the Study to ensure the exchange of relevant safety data within appropriate timeframes and in an appropriate format to enable the Parties to fulfill local and international regulatory reporting obligations and to facilitate appropriate safety reviews.  The Pharmacovigilance Agreement will include safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning any adverse experiences, pregnancy reports, and any other safety information arising from or related to the use of the Merck Compound and BioLineRx Compound in the Study, consistent with Applicable Law.  Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to Government Authorities.  BioLineRx will transmit to Merck serious adverse drug reactions (“SADRs”) and serious adverse events (“SAEs”) as follows:
 
5.1.1       For fatal and life-threatening SADRs, BioLineRx will send an early case notification to Merck within [*], followed by a completely processed case (on a CIOMS-1 form) within [*].
 
5.1.2       For all other SAEs, BioLineRx will send an early case notification to Merck within [*] followed by a completely processed case (on a CIOMS-1 form) within [*].