1.15 “Compounds” means the BioLineRx Compound and the Merck Compound. A “Compound” means either the BioLineRx Compound or the Merck Compound, as applicable.
1.16 “Combination” means the use or method of using the BioLineRx Compound and the Merck Compound in concomitant or sequential administration.
1.17 “Confidential Information” means any information, Know-How or other proprietary information or materials furnished to one Party (“Receiving Party”) by or on behalf of the other Party (“Disclosing Party”) pursuant to this Agreement, except to the extent that such information or materials: (a) was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the Disclosing Party, as demonstrated by competent evidence; (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party; (c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement; (d) was disclosed to the Receiving Party by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others; or (e) was subsequently developed by the Receiving Party without use of the Disclosing Party Confidential Information, as demonstrated by competent evidence.
1.18 “Continuing Party” has the meaning set forth in Section 10.1.3.
1.19 “Control” or “Controlled” means, with respect to particular information or intellectual property, that the applicable Party owns or has a license to such information or intellectual property and has the ability to grant a right, license or sublicense to the other Party as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.
1.20 “CTA” means an application to a Regulatory Authority for purposes of requesting the ability to start or continue a clinical trial.
1.21 “Data Sharing and Sample Testing Schedule” means the schedule attached hereto as Schedule I.
1.22 “Defending Party” has the meaning set forth in Section 14.2.3.
1.23 “Delivery” has the meaning set forth in Section 8.4.1.
1.24 “Direct Manufacturing Costs” has the meaning set forth in Section 6.12.
1.25 “Disposition Package” has the meaning set forth in Section 8.8.1.
1.26 “Dispute” has the meaning set forth in Section 22.1.
1.27 “Effective Date” has the meaning set forth in the preamble.
1.28 “EMA” has the meaning set forth in the definition of Applicable Law.
1.29 “Exclusion List” has the meaning set forth in the definition of Violation.
1.30 “FDA” has the meaning set forth in the definition of Applicable Law.
1.31 “Filing Party” has the meaning set forth in Section 10.1.3.