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. 3.8.1. All Clinical Data, including raw data and results, generated under this Agreement Data shall be jointly owned by BioLineRx Antigen Express and Merck. Merck hereby assigns to BioLineRx Antigen Express an undivided one-half interest in, to and under the Clinical Data. BioLineRx Antigen Express 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 Antigen Express shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term BioLineRx Term, Antigen Express shall grant Merck access to all Clinical Data and any portions of BioLineRx’s Antigen Express’ database that include Clinical Data. 3.8.2. Notwithstanding the foregoing, and subject to the remaining provisions of this Section 3.8, [*] before publication of the Clinical Data in accordance Article 12, (a) neither Party may disclose the Clinical Data publicly or to a Third Party without the consent of the other Party; and (b) in no event may (i) Merck use Clinical Data, directly or indirectly, to research, develop or commercialize a compound that is an Antigen Express Class Compound (whether as a monotherapy or in a combination other than pursuant to this Agreement) or (ii) Antigen Express use Clinical Data, directly or indirectly, to research, develop or commercialize a PD-1 Antagonist (whether as a monotherapy or in a combination other than pursuant to this Agreement). Each Party’s use of unpublished Clinical Data is restricted to (A) seeking regulatory approval for use of such Party’s Compound in the Combination; (B) prosecuting and enforcing Jointly Owned Inventions; (C) conducing Subsequent Studies; and (D) internal purposes related to its own Compound; provided, however, that the foregoing shall not limit or restrict either Party’s ability to (x) use or disclose the unpublished Clinical Data as may be necessary to comply with Applicable Law or as may be necessary to comply with its such Party’s internal policies and procedures with respect to pharmacovigilance and adverse event reporting. For , or (y) share with Third Parties or Affiliates Toxicity & Safety Data where because of severity, frequency or lack of reversibility either Party needs to use such Toxicity & Safety Data with respect to its own Compound or the avoidance of doubt, BioLineRx shall be free Combination 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 [*]ensure patient safety.

Ownership and Use of Clinical Data. 3.8.1 All Clinical Data other than Pembro Only Arm Data (the “Combination Data, including raw data and results, generated under this Agreement ”) shall be jointly owned by BioLineRx Company and MerckMSD. 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 [***] Company shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term BioLineRx Term, Company shall grant Merck MSD access to all Clinical Data and any portions of BioLineRx’s database that include Clinical Datafor uses permitted in this Agreement. [***]. 3.8.2 Notwithstanding the foregoingforegoing Section 3.8.1, and subject to before publication of the remaining provisions of this Section 3.8, Combination Data in accordance with Article 12: [*] **]; provided, however, that the foregoing shall not limit or restrict either Party’s ability to use the [***]. If a Party believes disclosure of Clinical Data as may be is necessary to comply with Applicable Law or as rules of a securities exchange, such Party shall promptly inform the other Party of the disclosure that is being sought, and consult and cooperate fully with the other Party in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Any information disclosed shall remain otherwise subject to the confidentiality and non-use provisions of this Section, and the Party disclosing such information shall take all steps reasonably necessary, including without limitation obtaining an order of confidentiality, to ensure the continued confidential treatment of such information. 3.8.3 Notwithstanding anything to the contrary in this Section 3.8, unpublished Clinical Data from the Study may be necessary used [***]. If MSD desires to comply update its label for the MSD Compound to add an indication involving administration of the MSD Compound in a Combination or if Company desires to seek Regulatory Approval of a Company Compound for an indication involving administration of the Company Compound in a Combination, in each case, based on the results of the Study, such Party shall notify the other Party at least [***] prior to submitting any Regulatory Documentation to initiate such label change or obtain such Regulatory Approval. [***] 3.8.4 Notwithstanding anything to the contrary in this Section 3.8, Company may: [***]; and (iii) Company must notify MSD at least [***] before such disclosure of the reasons for the planned disclosure [***] before such disclosure of the reasons for the planned disclosure and provide MSD with its internal policies a copy of the Combination Data and procedures topline results of the Pembro-Only Arm and any related summaries or analyses, as applicable, which are to be disclosed, and further provided that with respect to pharmacovigilance and adverse event reporting. For the avoidance of doubt, BioLineRx shall be free to use/share (including publish) data and topline results from the Study, including Clinical Data, which are solely related to the single-agent use of the BioLineRx Compound Pembro-Only Arm only, Company shall consider in good faith 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 implement MSD’s comments to the extent that consistent with such Clinical Data has been published as provided in Section 12.2 [*]Applicable Law, applicable securities laws and applicable rules of such securities exchange.

Ownership and Use of Clinical Data. 3.8.1. All Clinical Data, including raw data and results, generated under this Agreement shall be jointly owned by BioLineRx Company and MerckMerck (the “Jointly Owned Clinical Data”), with each Party having an undivided one-half interest. Without additional compensation, Merck hereby assigns assigns, and shall cause its Affiliates and Subcontractors to BioLineRx assign, to Company an undivided one-half interest in, to and under the Jointly Owned Clinical Data. BioLineRx Without additional compensation, Company hereby assigns assigns, and shall cause its Affiliates and Subcontractors to assign, to Merck an undivided one-half interest inn, to and under the Jointly Owned Clinical Data. If Prior to the completion of any such assignment, and if any such assignment cannot or does not occur, including in circumstances where occur because such assignment is precluded by law, the Party with the obligation to assign its right, title and interest in, to and under any applicable Clinical Data hereby grants the other Party a non-Party, with respect to the Jointly Owned Clinical Data, an exclusive (except as to the other Party), perpetual, irrevocable, worldwide license, with the right to grant sublicenses and to assign its license rights (subject to Section 3.8.2) to the Jointly Owned 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 Merck shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term BioLineRx Term, Merck shall grant Merck Company access to all Clinical Data and any portions of BioLineRx’s database that include such Clinical Data. 3.8.2. Notwithstanding the foregoing, before publication of the Jointly Owned Clinical Data in accordance Article 12, neither Party may disclose the Jointly Owned Clinical Data publicly or to a Third Party without the prior written consent of the other Party and subject each Party’s use of Clinical Data is restricted to: (1) seeking Regulatory Approval for use of such Party’s Compound in the Combination; (2) prosecution and enforcement of Jointly Owned Inventions, with respect to Merck, the remaining provisions Merck Inventions, and, with respect to Company, the Company Inventions, in each case, pursuant to this Agreement; (3) conducting research and additional clinical trials for the Combination; and (4) research and development of this Section 3.8, [*] provided, however, that the its own Compound. The foregoing shall not limit or restrict either Party’s ability to (A) use or disclose the Jointly Owned Clinical Data as may be necessary to comply with Applicable Law or as may be necessary to comply with its such Party’s internal policies and procedures with respect to pharmacovigilance and adverse event reporting. For , (B) share with Third Parties or Affiliates Toxicity and Safety Data where because of severity, frequency or lack of reversibility either Party needs to use such Toxicity and Safety Data with respect to its own Compound or the avoidance of doubtCombination to ensure patient safety, BioLineRx shall be free to use/share or (including publishC) 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 or disclose the Jointly Owned Clinical Data to a Third third party collaborator who has been engaged by the disclosing Party except to support development or commercialization of such disclosing Party’s Compound, but only if such third party collaborator [ * ]. Such third party collaborator must agree to be subject to the extent that such confidentiality and use restrictions set forth in this Agreement. Uses of the unpublished Jointly Owned Clinical Data has been published are limited solely to those uses expressly set forth in this Agreement, and all other uses by or on behalf of a Party or its Affiliates shall require the prior written consent of the other Party. For clarity, and notwithstanding anything to the contrary herein, (1) Merck hereby consents to disclosure by or on behalf of the Company of the unpublished Jointly Owned Clinical Data to Xxxxxx Xxxxx Medicament SA (“PFD”); provided, that, prior to sharing such unpublished Jointly Owned Clinical Data with PFD, PFD will be subject to non-use and confidentiality provisions regarding such Jointly Owned Clinical Data as provided stringent (including those set forth in Section 12.2 [*]3.8 of this Agreement) as those set forth herein and (2) nothing herein shall be construed as granting Merck or Company any right or license, whether expressly or impliedly, to make, have made, use, sell, offer for sale, import or export the Company Compound or the Merck Compound, respectively.

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.

Ownership and Use of Clinical Data. 3.10.1. [***]. Collaborator shall maintain the Joint Clinical Data and any MSD Clinical Data in its internal database; [***]. 3.10.2. All Collaborator Clinical Data, including raw data and results, generated under this Agreement Data shall be jointly solely owned by BioLineRx and MerckCollaborator. Merck All MSD Clinical Data shall be solely owned by MSD. In accordance with the foregoing, each Party hereby assigns to BioLineRx an undivided one-half interest the other its entire right, title and interest, if any, in, to and under the MSD Clinical DataData (with respect to Collaborator) and the Collaborator Clinical Data (with respect to MSD). 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 Where such assignment is precluded by lawApplicable Law or otherwise does not occur, the Party with the obligation otherwise obligated to assign such interest hereby grants the other Party a nonperpetual, irrevocable, worldwide, [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. royalty-free, fully paid-up exclusive license, license with the right to grant sublicenses and to assign its license rights such rights, to the MSD Clinical Data (with respect to any Person, the grant by Collaborator to MSD) and the Collaborator Clinical Data (with respect to the grant by MSD to Collaborator) in each case without the consent of the granting Party and without or any accounting to such the granting 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 MSD Clinical Data may be used by Collaborator solely to evaluate the safety or performance of the Combination or to register the Collaborator Compound 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 DataCombination. Notwithstanding the foregoing, and subject to the remaining provisions of this Section 3.8, except as [*] provided, however, that **]. 3.10.3. Before publication or presentation of a summary of 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 Joint 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 neither Party shall may disclose the Joint Clinical Data publicly or to a Third Party except to without the extent that consent of the other Party. Notwithstanding the foregoing, either Party may use and disclose such unpublished Joint Clinical Data has been published as provided in Section 12.2 : [***]. 3.10.4. Notwithstanding anything to the contrary in this Section 3.10 (Ownership and Use of Clinical Data), Collaborator may: [***].

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.