Common use of Ownership and Use of Clinical Data Clause in Contracts

Ownership and Use of Clinical Data. All Clinical Data, including raw data and results, generated under this Agreement shall be jointly owned by BioLineRx and Merck. Merck hereby assigns to BioLineRx an undivided one-half interest in, to and under the Clinical Data. BioLineRx hereby assigns to Merck an undivided one-half interest in, to and under the Clinical Data. If such assignment cannot or does not occur, including in circumstances where such assignment is precluded by law, the Party with the obligation to assign hereby grants the other Party a non-exclusive license, with the right to grant sublicenses and to assign its license rights to the Clinical Data to any Person, in each case without the consent of the granting Party and without any accounting to such Party; provided that each such sublicensee and assignee is bound in writing to comply with the terms of this Agreement that are relevant to use and exploitation of such Clinical Data. BioLineRx shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term BioLineRx shall grant Merck access to all Clinical Data and any portions of BioLineRx’s database that include Clinical Data. Notwithstanding the foregoing, and subject to the remaining provisions of this Section 3.8, [*] provided, however, that the foregoing shall not limit or restrict either Party’s ability to use the Clinical Data as may be necessary to comply with Applicable Law or as may be necessary to comply with its internal policies and procedures with respect to pharmacovigilance and adverse event reporting. For the avoidance of doubt, BioLineRx shall be free to use/share (including publish) data and results from the Study, including Clinical Data, which are solely related to the single-agent use of the BioLineRx Compound and are not related to the Combination, and which have been generated during the treatment period in which the BioLineRx Compound is used in monotherapy. Neither Party shall disclose the Clinical Data to a Third Party except to the extent that such Clinical Data has been published as provided in Section 12.2 [*].

Ownership and Use of Clinical Data. All Subject to Section 3.6(e), and subject to and solely to the extent expressly approved by the relevant IRB and permitted under applicable Law (and without violating the rights of any Third Party), all Clinical Data, including raw data and results, Data generated under this Agreement (solely in the Field and excluding (i) any regulatory filings submitted to any Governmental Authority, and (ii) rights in and to any Inventions or Patent Rights that arise out of or in relation to, or are otherwise embodied in, such data) shall be jointly owned by BioLineRx Protalix and Merck. Merck hereby assigns to BioLineRx Chiesi (the “Jointly Owned Clinical Data”), with each Party having an undivided one-half interest in, to and under the Clinical Data. BioLineRx hereby assigns to Merck an undivided one-half interest in, to and under the Clinical Datatherein. If any such assignment joint ownership cannot or does not occur, including in circumstances where occur because such assignment joint ownership is precluded by lawapplicable Law, violates the rights of a Third Party or has not been expressly approved by the relevant IRB, the Party with the obligation to assign that owns such Clinical Data hereby grants the other Party a non-exclusive licenseexclusive, with the right perpetual, irrevocable, worldwide license to grant sublicenses and to assign its license rights to the such Clinical Data to any PersonData, in each case without the consent of the granting Party and without any accounting to such Party; provided that each , solely for use in a manner consistent with such sublicensee and assignee is bound in writing to comply with the terms of Party’s rights under this Agreement that are relevant to use and exploitation of such Clinical Data. BioLineRx shall maintain the Clinical Data in its internal database; providedEx-US Agreement (and, however, that at all times during the Term BioLineRx shall grant Merck access to all Clinical Data and any portions of BioLineRx’s database that include Clinical Data. Notwithstanding the foregoing, and subject to the remaining provisions of this Section 3.8, [*] provided, however, that the foregoing shall not limit or restrict either Party’s ability to use the Clinical Data as may be necessary to comply with Applicable Law or as may be necessary to comply with its internal policies and procedures with respect to pharmacovigilance and adverse event reportingChiesi as licensee, solely in the Field in the Territory). For the avoidance of doubt, BioLineRx shall be free the ownership rights to use/share (including publish) data and results from the Study, including Clinical Data, which are solely related to the single-agent use of the BioLineRx Compound and are not related to the Combination, and which have been generated during the treatment period in which the BioLineRx Compound is used in monotherapy. Neither Party shall disclose the Jointly Owned Clinical Data provided for in this Section 3.6(j) shall not include or apply to a Third Party except to the extent any Inventions or Patent Rights that arise out of or in relation to, or are otherwise embodied in, any such Clinical Data has been published as provided (or the collection, generation or use thereof). For the avoidance of doubt, Chiesi’s use of Jointly Owned Clinical Data is restricted to exercising its rights hereunder with respect to Licensed Product in Section 12.2 the Field in the Territory and under the Ex-US Agreement with respect to Licensed Product in the Field outside the Territory. [*]**] Redacted pursuant to confidential treatment request.

Ownership and Use of Clinical Data. All Clinical Data, including raw data from the electronic database and results, generated under this Agreement shall be jointly owned by BioLineRx Xxxxxxxx. Xxxxxxxx shall xxxxx and Merck. Merck hereby assigns to BioLineRx an undivided one-half interest in, to and under the Clinical Data. BioLineRx hereby assigns to Merck an undivided one-half interest in, to and under the Clinical Data. If such assignment cannot or does not occur, including in circumstances where such assignment is precluded by law, the Party with the obligation to assign hereby grants the other Party ImmunoGen a non-exclusive licenseexclusive, worldwide, irrevocable, perpetual, fully paid-up, royalty-free license to use the Clinical Data for research and development of the ImmunoGen Compound (including any product, or combination therapy including such), with the right to grant sublicenses and sublicense such license to assign its license rights a third party licensee of the ImmunoGen Compound (including any product, or combination therapy including such), subject to the Clinical Data obligations of confidentiality and restrictions on publications applicable to any Person, in each case without the consent of the granting Party and without any accounting to such Party; provided that each such sublicensee and assignee is bound in writing to comply with the terms of this Agreement that are relevant to use and exploitation of such Clinical Data. BioLineRx shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term BioLineRx shall grant Merck access to all Clinical Data and any portions of BioLineRx’s database that include Clinical DataImmunoGen hereunder. Notwithstanding the foregoing, and subject to the remaining provisions of this Section 3.8, [*] provided, however, that the foregoing shall not limit or restrict either Party’s ability to ImmunoGen may use the Clinical Data in accordance with this Agreement for regulatory submissions or in connection with discussions with Regulatory Authorities in any jurisdiction. Xxxxxxxx shall be responsible for maintaining the Clinical Data in a validated system. Notwithstanding the foregoing, during the Term, (i) Xxxxxxxx covenants and agrees that it and its Affiliates may not use the Clinical Data, directly or indirectly, to research, develop or commercialize an ImmunoGen Class Compound other than the ImmunoGen Compound in combination with a Xxxxxxxx Class Compound, and (ii) ImmunoGen covenants and agrees that it and its Affiliates may not use the Clinical Data, directly or indirectly, to research, develop or commercialize a Xxxxxxxx Class Compound other than the Xxxxxxxx Compound in combination with an ImmunoGen Class Compound, in each case (i) and (ii), except as may be necessary to comply with Applicable Law or as may be necessary to comply with its internal policies and procedures with respect to pharmacovigilance and adverse event reporting. For clarity, the avoidance of doubtforegoing sentence shall not restrict Xxxxxxxx or ImmunoGen from otherwise researching, BioLineRx shall be free to use/share (including publish) data and results from developing or commercializing an ImmunoGen Class Compound or Xxxxxxxx Class Compound, respectively, without the Study, including Clinical Data, which are solely related to the single-agent use of the BioLineRx Compound and are not related to the Combination, and which have been generated during the treatment period in which the BioLineRx Compound is used in monotherapy. Neither Party shall disclose the Clinical Data to a Third Party except to the extent that such Clinical Data has been published as provided in Section 12.2 [*]Data.