Confidentiality Publication. 8.1 In fulfilling their obligations under this License Agreement, it may be desirable or necessary for the parties to disclose to one another certain of their Confidential Information. In the event of receipt of such Confidential Information, the receiving party agrees to preserve such information as confidential and not to disclose it to third parties or to use it except in connection with this License Agreement for a period of seven and one-half (7.5) years after receipt. The foregoing obligations shall not apply to any information that: (a) is now in the public domain or becomes generally available to the public through no fault of the receiving party; (b) is already known to, or in the possession of, the receiving party as can be demonstrated by documentary evidence; (c) is disclosed to the receiving party on a nonconfidential basis by a third party having the right to make such disclosure; or (d) is independently developed by the receiving party as can be demonstrated by documentary evidence. In addition, to the extent reasonably necessary to fulfill its obligations or exercise its rights under this License Agreement (i) a party may disclose Confidential Information to its Affiliates, Sublicensees, consultants, outside contractors and clinical investigators, on a need-to-know basis on condition that such persons or entities agree to be bound by the provisions of this Section 8.1, (ii) a party or its Affiliates or Sublicensees may disclose Confidential Information to governmental or other regulatory authorities to the extent that such disclosure is reasonably necessary to obtain patents or regulatory authorizations, provided the disclosing party shall request confidential treatment thereof, and (iii) a party may disclose Confidential Information as required by applicable law, regulation or judicial process, provided that such party shall give the other party (x) prior written notice thereof, (y) adequate opportunity to object to any such disclosure or to request confidential treatment thereof, and (z) shall take all steps reasonably possible to minimize the disclosure to that level mandated by law. 8.2 The parties may make a joint announcement of the existence of this License Agreement. Licensee and its Sublicensees may announce clinical, regulatory and commercial developments related to Licensed Products. Other than as described above, Southern Research Institute License Agreement 12 neither party shall publish any news release or other public announcement, written or oral, announcing this License Agreement or any performance thereunder, except to the extent required by law in the reasonable opinion of legal counsel for the originating party (written notice of such opinion being given to the other party prior to publication and such publication delayed for a reasonable time to allow the nonpublishing party to respond) or to the extent mutually agreed by the parties. 8.3 Southern and Licensee hereby reaffirm their obligations pursuant to Section 11 of the Research Agreement.
Appears in 2 contracts
Samples: License Agreement (Corixa Corp), License Agreement (Corixa Corp)
Confidentiality Publication. 8.1 In fulfilling their 5.1 Subject to Clause 5.5, each Party shall keep confidential and not disclose to any third party (other than the Experts, Contributors, Ethics Committee, Regulatory Authority, and staff involved in carrying out the Clinical Trial on a need to know basis) any Confidential Information disclosed to it by another Party (the “Disclosing Party”) without the prior written consent of the Disclosing Party. For the avoidance of doubt, the Charity shall be permitted to disclose Confidential Information disclosed to it to CRT and CRT shall be permitted to disclose Confidential Information disclosed to it to the Charity. Any party to whom Confidential Information is disclosed in accordance with this Clause 5.1 shall be:
5.1.1 subject to no less onerous obligations than those contained in this Clause 5 to keep such information confidential; and
5.1.2 advised of its confidential nature.
5.2 The obligations of confidence referred to in Clause 5.1 shall not apply to any part of the Confidential Information which can be proved by evidence in writing:
5.2.1 was known to the recipient Party (the “Recipient Party”) before its disclosure by the Disclosing Party;
5.2.2 was available to the public before that date or was otherwise in the public domain;
5.2.3 becomes available to the public or enters the public domain after that date otherwise than as a result of an act or default of the Recipient Party;
5.2.4 is received by the Recipient Party from a third party not bound to the Disclosing Party by any obligation of secrecy;
5.2.5 is independently developed or generated by the Recipient Party in circumstances where it has not been derived directly or indirectly from the Disclosing Party’s Confidential Information; or
5.2.6 is required to be disclosed by: (i) any law or statute or any rule or regulation of any Regulatory Authority or other government or administrative agency or authority, (ii) a Regulatory Authority; or (iii) an order of any court, provided however, that in each such event the Recipient Party required to disclose the Confidential Information shall give prompt notice to the Disclosing Party of such requirement so that such Disclosing Party may seek a protective order or other appropriate remedy to the extent of such disclosure. Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 24b-2 of the Exchange Act of 1934, as amended. Confidential Portions are marked: [***].
5.3 The obligations of the Parties under Clause 5.1 shall survive the expiry or termination of this Agreement for whatever reason for a period of ten (10) years from the date of such expiry or termination.
5.4 Each of the Parties agrees that the provisions of this Clause 5 are fair and reasonable and that money damages are not a sufficient remedy for any breach of this Clause 5 and therefore, in addition to all other remedies, all Parties shall be entitled to seek injunctive or other equitable relief as a remedy for such breach.
5.5 Notwithstanding any confidentiality obligations assumed by the Parties hereunder, the Parties acknowledge the importance of publications to the academic standing of the Charity and the Contributors and the capital raising, transactional, and licensing prospects and reporting and disclosure obligations of the Company under United States and other securities laws, and progress reporting obligations to licensors and sublicensors under Third Party Licences. Accordingly, the Parties have agreed as follows as regards publication of Clinical Trial Results and Progress Reports:
5.5.1 The Charity shall use reasonable endeavours to publish, or procure the publication by the Contributors of, the Clinical Trial Results in a timely manner in accordance with generally accepted academic practice, whether during the course of or after completion of the Clinical Trial;
5.5.2 The Company may disclose the content of Progress Reports only to the extent required for (a) satisfying mandatory reporting and disclosure obligations under United States and other securities laws; or (b) to existing licensors or sublicensors of the Company in order to comply with reporting obligations in existence as at the date of this License Agreementagreement under Third Party Licences, provided that in the case of (b) the disclosure will exclude all information regarding clinical responses and shall be limited to only information regarding the clinical indication, anticipated timelines of the trial, the number of patients dose, and such other information of a similar nature as may be reasonably required by the Third Party Licence;
5.5.3 In the event that the Company wishes to disclose the content of Progress Reports to a third party in connection with capital raising, financing, transactional, and/or licensing activities or prospects for the benefit of the Company, it shall give notice to the Charity, including details of the content of the proposed disclosure and the reason for wishing to make such disclosure, and obtain the Charity’s approval before proceeding with the disclosure. The Company shall inform Charity of the identity of the third party in its notice unless it is prevented from doing so due to express confidentiality restrictions owed to the third party, in which case the Company shall state the main business area within which the third party operates; and
5.5.4 It is further provided that any disclosure of the content of Progress Reports by the Company shall be subject to the following conditions: (a) all recipients shall be informed in writing beforehand of the confidential nature of the information being disclosed and shall have agreed in writing to obligations of confidentiality in favour of the Company no less onerous than those contained in this Clause 5 (but without any right of further disclosure) to keep such information confidential; and (b) only the content of the documents containing the relevant information which has been processed into a suitable format may be desirable or necessary disclosed but not copies of the actual documents themselves. Condition (a) above shall not apply to a disclosure by the Company for the parties purpose mentioned in Clause 5.5.2(a). Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to disclose a Request for Confidential Treatment under Rule 24b-2 of the Exchange Act of 1934, as amended. Confidential Portions are marked: [***].
5.6 The Charity will include provisions in its contracts with the Contributor(s) that require such Contributor(s) to notify the Charity in advance of submission of any abstract, presentation or manuscript incorporating Clinical Trial Results that the Contributor(s) wish to publish or have published or to present or have presented.
5.7 Upon receipt of such notification from a Contributor or if the Charity wishes itself to publish or have published or to present or have presented an abstract, presentation or manuscript incorporating Clinical Trial Results the Charity shall so notify the Company and CRT and provide (in so far as it is able to do so in the case of a Contributor’s notification) in response to the Company’s and/or CRT’s reasonable request a copy or summary thereof at least seven (7) days prior to submission for publication of an abstract or presentation or at least thirty (30) days prior to submission for publication of a manuscript (or twenty one another certain (21) days prior to submission for publication of their a manuscript in the case of a Contributor’s notification). Any such copy or summary shall provide sufficient details to enable the Company and CRT to ascertain whether it contains Confidential InformationInformation of the Company or CRT respectively or whether Patent Rights or other proprietary protection should be sought.
5.8 The Company and CRT shall review and make any comments on such intended publication or presentation of an abstract to the Charity within seven (7) days and/or shall review and make any comments on such intended publication or presentation of a manuscript within thirty (30) days. The Company and/or CRT may request that:
5.8.1 Confidential Information of the Company (not including Clinical Trial Results nor information directly relating to the Investigational Medicinal Product) or Confidential Information of CRT (not including Clinical Trial Results) be removed from the proposed publication or presentation; and/or
5.8.2 any such publication or presentation be delayed if in the Company’s or CRT’s reasonable opinion it is necessary to delay publication or presentation in order to file a patent application or application for other proprietary protection in respect of any invention made in the course of the Clinical Trial. Any such delay will be kept to the minimum period practicable and will in no event extend beyond thirty (30) days from the date the proposed publication or presentation was provided to the Company. In the event of receipt of such Confidential Informationa request pursuant to Clauses 5.8.1 or 5.8.2, the receiving party agrees Company or CRT (as the case may be) shall provide the Charity with a written explanation of the reasons why it believes information should be removed or a delay is necessary. For the avoidance of doubt, any Patent Rights filed pursuant to preserve such Clause 5.8.2 shall be filed in CRT’s name.
5.9 The Charity and CRT shall be entitled to publish information as confidential and not to disclose it to third parties or to use it except in connection with this License Agreement for a period of seven and one-half (7.5) years after receipt. The foregoing obligations shall not apply to any information that:
(a) is now in the public domain or becomes generally available relation to the public through no fault proposed Clinical Trial, including that it is or will be a trial conducted by the Clinical Development Partnerships initiative set up by the Charity and CRT, the pre-requisites for patient recruitment, a brief description of the receiving party;
(b) is already known toClinical Trial, or in including the possession ofname of the Company, the receiving party as can be demonstrated by documentary evidence;
(c) is disclosed to the receiving party on a nonconfidential basis by a third party having the right to make such disclosure; or
(d) is independently developed by the receiving party as can be demonstrated by documentary evidence. In addition, to the extent reasonably necessary to fulfill its obligations or exercise its rights under this License Agreement (i) a party may disclose Confidential Information to its Affiliates, Sublicensees, consultants, outside contractors reference number and clinical investigators, on a need-to-know basis on condition that such persons or entities agree to be bound by the provisions of this Section 8.1, (ii) a party or its Affiliates or Sublicensees may disclose Confidential Information to governmental or other regulatory authorities to the extent that such disclosure is reasonably necessary to obtain patents or regulatory authorizations, provided the disclosing party shall request confidential treatment thereof, and (iii) a party may disclose Confidential Information as required by applicable law, regulation or judicial process, provided that such party shall give the other party (x) prior written notice thereof, (y) adequate opportunity to object to any such disclosure or to request confidential treatment thereof, and (z) shall take all steps reasonably possible to minimize the disclosure to that level mandated by law.
8.2 The parties may make a joint announcement class of the existence of this License Agreement. Licensee Investigational Medicinal Product and its Sublicensees may announce clinical, regulatory and commercial developments related to Licensed Products. Other than as described above, Southern Research Institute License Agreement 12 neither party shall publish any news release or other public announcement, written or oral, announcing this License Agreement or any performance thereunder, except to the extent required by law in location(s) at which the reasonable opinion of legal counsel for the originating party (written notice of such opinion being given to the other party prior to publication and such publication delayed for a reasonable time to allow the nonpublishing party to respond) or to the extent mutually agreed by the partiestrial is taking place.
8.3 Southern and Licensee hereby reaffirm their obligations pursuant to Section 11 of the Research Agreement.
Appears in 2 contracts
Samples: Clinical Trial and Option Agreement (Asterias Biotherapeutics, Inc.), Clinical Trial and Option Agreement (Biotime Inc)
Confidentiality Publication. 8.1 In fulfilling their 7.1 With respect to all Confidential Information, each Party agrees as follows:
a. each Party shall treat as confidential, not disclose to Third Parties and preserve the confidentiality of all Confidential Information of the other Party [***];
b. each Party (“receiving Party”) shall use Confidential Information of the other Party (“disclosing Party”) or any of its Affiliates (including but not limited to the disclosing Party’s Background Confidential Information), [***] and/or for the practice of the licenses to the respective Confidential Information granted to such receiving Party under this Agreement, and shall exercise due care to prevent its unauthorized disclosure;
c. Notwithstanding Section 7.1(a) – (b), a Party may: (i) disclose Confidential Information of the other Party in connection with an order of a court or other government body or as otherwise required by or in compliance with law or regulation; provided that the disclosing Party (A) provides the other Party with notice of any such required disclosure in advance of such disclosure so that the disclosing Party may seek a protective order or other appropriate remedy, (B) discloses only that portion of the Confidential Information that it is advised by counsel that it is legally required to disclose, and (C) exercises reasonable efforts to cooperate with the disclosing Party should it seek to obtain a protective order or other assurance that confidential treatment will be accorded to such Confidential Information; (ii) [***] (iii) [***] (iv) [***]; so long as, in each case of the foregoing clauses (iii) and (iv), the person and/or Entity to which disclosure is made is subject to confidentiality and non-use obligations at least as protective as the obligations under this License Agreement, it may be desirable or necessary for .
d. The obligation to maintain the parties to disclose to one another certain of their Confidential Information. In the event of receipt of such Confidential Information, the receiving party agrees to preserve such information as confidential and not to disclose it to third parties or to use it except in connection with this License Agreement for a period of seven and one-half (7.5) years after receipt. The foregoing obligations shall not apply to any information that:
(a) is now in the public domain or becomes generally available to the public through no fault of the receiving party;
(b) is already known to, or in the possession of, the receiving party as can be demonstrated by documentary evidence;
(c) is disclosed to the receiving party on a nonconfidential basis by a third party having the right to make such disclosure; or
(d) is independently developed by the receiving party as can be demonstrated by documentary evidence. In addition, to the extent reasonably necessary to fulfill its obligations or exercise its rights under this License Agreement (i) a party may disclose disclosing Party’s Confidential Information to its Affiliates, Sublicensees, consultants, outside contractors and clinical investigators, on a need-to-know basis on condition that such persons in confidence shall cease [***] after the Expiration or entities agree to be bound by the provisions Termination of this Section 8.1, (ii) a party or its Affiliates or Sublicensees may disclose Confidential Information to governmental or other regulatory authorities to the extent that such disclosure is reasonably necessary to obtain patents or regulatory authorizations, provided the disclosing party shall request confidential treatment thereof, and (iii) a party may disclose Confidential Information as required by applicable law, regulation or judicial process, provided that such party shall give the other party (x) prior written notice thereof, (y) adequate opportunity to object to any such disclosure or to request confidential treatment thereof, and (z) shall take all steps reasonably possible to minimize the disclosure to that level mandated by law.
8.2 The parties may make a joint announcement of the existence of this License Agreement. Licensee and its Sublicensees may announce clinical, regulatory and commercial developments related to Licensed Products. Other than as described above, Southern Research Institute License Agreement 12 neither party shall publish any news release or other public announcement, written or oral, announcing this License Agreement or any performance thereunder, except to the extent required by law in the reasonable opinion of legal counsel for the originating party (written notice of such opinion being given to the other party prior to publication and such publication delayed for a reasonable time to allow the nonpublishing party to respond) or to the extent mutually agreed by the parties.
8.3 Southern and Licensee hereby reaffirm their obligations pursuant to Section 11 of the Research Agreement.[***]
Appears in 2 contracts
Samples: Collaboration and License Agreement (Caribou Biosciences, Inc.), Collaboration and License Agreement (Caribou Biosciences, Inc.)
Confidentiality Publication. 8.1 In fulfilling their 5.1 Subject to Clause 5.5, each Party shall keep confidential and not disclose to any third party (other than the Experts, Contributors, Ethics Committee, Regulatory Authority and staff involved in carrying out the Clinical Trial on a need to know basis) any Confidential Information disclosed to it by another Party (the “Disclosing Party”) without the prior written consent of the Disclosing Party. For the avoidance of doubt, the Charity shall be permitted to disclose Confidential Information disclosed to it to CRT and CRT shall be permitted to disclose Confidential Information disclosed to it to the Charity. Any party to whom Confidential Information is disclosed in accordance with this Clause 5.1 shall be:
5.1.1 subject to no less onerous obligations than those contained in this Clause 5 to keep such information confidential; and
5.1.2 advised of its confidential nature.
5.2 The obligations of confidence referred to in Clause 5.1 shall not apply to any part of the Confidential Information which can be proved by evidence in writing:
5.2.1 was known to the recipient Party (the “Recipient Party”) before its disclosure by the Disclosing Party;
5.2.2 was available to the public before that date or was otherwise in the public domain;
5.2.3 becomes available to the public or enters the public domain after that date otherwise than as a result of an act or default of the Recipient Party;
5.2.4 is received by the Recipient Party from a third party not bound to the Disclosing Party by any obligation of secrecy;
5.2.5 is independently developed or generated by the Recipient Party in circumstances where it has not been derived directly or indirectly from the Disclosing Party’s Confidential Information; or
5.2.6 is required to be disclosed by: (i) law, (ii) a Regulatory Authority; or (iii) an order of any court, provided however, that in each such event the Recipient Party required to disclose the Confidential Information shall give prompt notice to the Disclosing Party of such requirement so that such Disclosing Party may seek a protective order or other appropriate remedy to the extent of such disclosure.
5.3 The obligations of the Parties under Clause 5.1 shall survive the expiry or termination of this Agreement for whatever reason for a period of ten (10) years from the date of such expiry or termination.
5.4 Each of the Parties agrees that the provisions of this Clause 5 are fair and reasonable and that money damages are not a sufficient remedy for any breach of this Clause 5 and therefore, in addition to all other remedies, all Parties shall be entitled to seek injunctive or other equitable relief as a remedy for such breach.
5.5 Notwithstanding any confidentiality obligations assumed by the Parties hereunder, the Parties acknowledge: i) the importance of publications to the academic standing of the Charity and the Contributors; and ii) the capital raising, transactional, and licensing prospects of the Company; and iii) the reporting and disclosure obligations of the Company to its investors and to XOMA under the XOMA Licence. Accordingly, the Parties have agreed as follows as regards publication of Clinical Trial Results and Progress Reports:
5.5.1 The Charity shall use reasonable endeavours to publish, or procure the publication by the Contributors of, the Clinical Trial Results in a timely manner in accordance with generally accepted academic practice, whether during the course of or after completion of the Clinical Trial.
5.5.2 The Company may disclose the content of Progress Reports to XOMA only to the extent it is required to do so under the XOMA Licence, provided that the disclosure will exclude all information regarding clinical responses and shall be limited to only information regarding the clinical indication, anticipated timelines of the trial, the number of patients dosed, and such other information of a similar nature as may be reasonably required by the XOMA Licence.
5.5.3 The Company may disclose:
(a) the content of Progress Reports to a third party in connection with capital raising, financing, transactional, and/or licensing activities or prospects for the benefit of the Company. Prior to making such disclosure, the Company shall give notice to the Charity, including details of the content of the proposed disclosure and the reason for wishing to make such disclosure, and shall inform the Charity of the identity of the third party in its notice unless it is prevented from doing so due to express confidentiality restrictions owed to, and requested by, the third party, in which case the Company shall state the main business area within which the third party operates. The Company may, without the Charity’s prior approval, disclose only the clinical indication, anticipated timelines of the trial, and the number of patients dosed, but shall obtain the Charity’s approval before proceeding with any other disclosure under this License AgreementClause 5.5.3(a);
(b) the Final Report to the Company’s consultants and professional advisors, solely for the purpose of assisting in the evaluation of the results with a view to exercise of the Option and provided that no patient data shall be disclosed unless it has been cleansed; and
(c) the content of Progress Reports to persons holding investments in the Company, solely for the purpose of a status update, such as periodic disclosure of recruitment numbers to investors in the Company by way of demonstration of progress in the Clinical Trial.
5.5.4 It is further provided that each disclosure of the content of Progress Reports by the Company under this Clause 5.5 shall be subject to the following conditions:
(a) all recipients shall be informed in writing beforehand of the confidential nature of the information being disclosed and shall have agreed in writing to obligations of confidentiality in favour of the Company no less onerous than those contained in this Clause 5 (but without any right of further disclosure) to keep such information confidential; and
(b) only the content of the documents containing the relevant information which has been processed into a suitable format may be desirable disclosed but not copies of the actual documents themselves.
5.6 The Charity will include provisions in its contracts with the Contributor(s) that require such Contributor(s) to notify the Charity in advance of submission of any abstract, presentation or manuscript incorporating Clinical Trial Results that the Contributor(s) wish to publish or have published or to present or have presented.
5.7 Upon receipt of such notification from a Contributor or if the Charity wishes itself to publish or have published or to present or have presented an abstract, presentation or manuscript incorporating Clinical Trial Results the Charity shall so notify the Company and CRT and provide (in so far as it is able to do so in the case of a Contributor’s notification) in response to the Company’s and/or CRT’s reasonable request a copy or summary thereof at least seven (7) days prior to submission for publication of an abstract or presentation or at least thirty (30) days prior to submission for publication of a manuscript (or twenty one (21) days prior to submission for publication of a manuscript in the case of a Contributor’s notification). Any such copy or summary shall provide sufficient details to enable the Company and CRT to ascertain whether it contains Confidential Information of the Company or CRT respectively or whether Patent Rights or other proprietary protection should be sought.
5.8 The Company and CRT shall review and make any comments on such intended publication or presentation of an abstract to the Charity within seven (7) days and/or shall review and make any comments on such intended publication or presentation of a manuscript within thirty (30) days. The Company and/or CRT may request that:
5.8.1 Confidential Information of the Company (not including Clinical Trial Results nor information directly relating to the Investigational Medicinal Product) or Confidential Information of CRT (not including Clinical Trial Results) be removed from the proposed publication or presentation; and/or
5.8.2 any such publication or presentation be delayed if in the Company’s or CRT’s reasonable opinion it is necessary to delay publication or presentation in order to file a patent application or application for other proprietary protection in respect of any invention made in the parties course of the Clinical Trial. Any such delay will be kept to disclose the minimum period practicable and will in no event extend beyond thirty (30) days from the date the proposed publication or presentation was provided to one another certain of their Confidential Informationthe Company. In the event of receipt of such Confidential Informationa request pursuant to Clauses 5.8.1 or 5.8.2, the receiving party agrees to preserve such information Company or CRT (as confidential and not to disclose it to third parties or to use it except in connection the case may be) shall provide the Charity with this License Agreement for a period of seven and one-half (7.5) years after receipt. The foregoing obligations shall not apply to any information that:
(a) is now in the public domain or becomes generally available to the public through no fault written explanation of the receiving party;
(b) reasons why it believes information should be removed or a delay is already known tonecessary. For the avoidance of doubt, or any Patent Rights filed pursuant to Clause 5.8.2 shall be filed in the possession of, the receiving party as can be demonstrated by documentary evidence;
(c) is disclosed to the receiving party CRT’s name unless any Company personnel are deemed inventors on a nonconfidential basis by a third party having the right to make such disclosure; or
(d) is independently developed by the receiving party as can be demonstrated by documentary evidence. In addition, to the extent reasonably necessary to fulfill its obligations or exercise its rights under this License Agreement (i) a party may disclose Confidential Information to its Affiliates, Sublicensees, consultants, outside contractors and clinical investigators, on a need-to-know basis on condition that such persons or entities agree to be bound by the provisions of this Section 8.1, (ii) a party or its Affiliates or Sublicensees may disclose Confidential Information to governmental or other regulatory authorities to the extent that such disclosure is reasonably necessary to obtain patents or regulatory authorizations, provided the disclosing party shall request confidential treatment thereof, and (iii) a party may disclose Confidential Information as required by applicable law, regulation or judicial process, provided that such party shall give the other party (x) prior written notice thereof, (y) adequate opportunity to object to any such disclosure or to request confidential treatment thereoffiling, in which case such Patent Right shall be filed in both CRT’s and (z) Company’s names. As used herein, inventorship shall take all steps reasonably possible to minimize the disclosure to that level mandated by be determined in accordance with English law.
8.2 5.9 The parties may make Charity and CRT shall be entitled to publish information in relation to the proposed Clinical Trial, including that it is or will be a joint announcement trial conducted by the Clinical Development Partnerships initiative set up by the Charity and CRT, the pre-requisites for patient recruitment, a brief description of the existence Clinical Trial, including the name of the Company, the reference number and class of the Investigational Medicinal Product and the location(s) at which the trial is taking place.
5.10 In addition to the disclosures under Clause 5.5, the Company may disclose the commercial terms of this License Agreement to any actual or potential investors, bankers, acquirers, acquirees or merger partners, in each case under appropriate confidentiality provisions substantially equivalent to those of this Agreement. Licensee [***] = Confidential Information has been omitted and its Sublicensees may announce clinicalfiled separately with the Securities and Exchange Commission. Confidential treatment has been approved with respect to the omitted information, regulatory and commercial developments related pursuant to Licensed Products. Other than an Order dated January 8, 2018.
5.11 Except as described aboveexpressly permitted in Clause 5, Southern Research Institute License Agreement 12 neither party the Company shall publish not disclose the Clinical Trial Results to any news release potential investors, licensees or other public announcement, written or oral, announcing this License Agreement sub-licensees of the Company (or any performance thereunder, except to other person) until the extent required by law in Company has been granted the reasonable opinion of legal counsel for the originating party (written notice of such opinion being given to the other party prior to publication and such publication delayed for a reasonable time to allow the nonpublishing party to respond) or to the extent mutually agreed by the partiesLicence.
8.3 Southern and Licensee hereby reaffirm their obligations pursuant to Section 11 of the Research Agreement.
Appears in 1 contract
Samples: Clinical Trial and Option Agreement (Monopar Therapeutics)
Confidentiality Publication. 8.1 In fulfilling their 5.1 Subject to Clause 5.5, each Party shall keep confidential and not disclose to any third party (other than the Experts, Contributors, Ethics Committee, Regulatory Authority, and staff involved in carrying out the Clinical Trial on a need to know basis) any Confidential Information disclosed to it by another Party (the “Disclosing Party”) without the prior written consent of the Disclosing Party. For the avoidance of doubt, the Charity shall be permitted to disclose Confidential Information disclosed to it to CRT and CRT shall be permitted to disclose Confidential Information disclosed to it to the Charity. Any party to whom Confidential Information is disclosed in accordance with this Clause 5.1 shall be:
5.1.1 subject to no less onerous obligations than those contained in this Clause 5 to keep such information confidential; and
5.1.2 advised of its confidential nature.
5.2 The obligations of confidence referred to in Clause 5.1 shall not apply to any part of the Confidential Information which can be proved by evidence in writing:
5.2.1 was known to the recipient Party (the “Recipient Party”) before its disclosure by the Disclosing Party;
5.2.2 was available to the public before that date or was otherwise in the public domain;
5.2.3 becomes available to the public or enters the public domain after that date otherwise than as a result of an act or default of the Recipient Party;
5.2.4 is received by the Recipient Party from a third party not bound to the Disclosing Party by any obligation of secrecy;
5.2.5 is independently developed or generated by the Recipient Party in circumstances where it has not been derived directly or indirectly from the Disclosing Party’s Confidential Information; or
5.2.6 is required to be disclosed by: (i) any law or statute or any rule or regulation of any Regulatory Authority or other government or administrative agency or authority, (ii) a Regulatory Authority; or (iii) an order of any court, provided however, that in each such event the Recipient Party required to disclose the Confidential Information shall give prompt notice to the Disclosing Party of such requirement so that such Disclosing Party may seek a protective order or other appropriate remedy to the extent of such disclosure. Confidential treatment has been requested for certain portions of this exhibit pursuant to a request for confidential treatment under Rule 24b-2 of the Exchange Act of 1934, as amended. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Confidential portions are marked: [***].
5.3 The obligations of the Parties under Clause 5.1 shall survive the expiry or termination of this Agreement for whatever reason for a period of ten (10) years from the date of such expiry or termination.
5.4 Each of the Parties agrees that the provisions of this Clause 5 are fair and reasonable and that money damages are not a sufficient remedy for any breach of this Clause 5 and therefore, in addition to all other remedies, all Parties shall be entitled to seek injunctive or other equitable relief as a remedy for such breach.
5.5 Notwithstanding any confidentiality obligations assumed by the Parties hereunder, the Parties acknowledge the importance of publications to the academic standing of the Charity and the Contributors and the capital raising, transactional, and licensing prospects and reporting and disclosure obligations of the Company under United States and other securities laws, and progress reporting obligations to licensors and sublicensors under Third Party Licences. Accordingly, the Parties have agreed as follows as regards publication of Clinical Trial Results and Progress Reports:
5.5.1 The Charity shall use reasonable endeavours to publish, or procure the publication by the Contributors of, the Clinical Trial Results in a timely manner in accordance with generally accepted academic practice, whether during the course of or after completion of the Clinical Trial;
5.5.2 The Company may disclose the content of Progress Reports only to the extent required for (a) satisfying mandatory reporting and disclosure obligations under United States and other securities laws; or (b) to existing licensors or sublicensors of the Company in order to comply with reporting obligations in existence as at the date of this License Agreementagreement under Third Party Licences, provided that in the case of (b) the disclosure will exclude all information regarding clinical responses and shall be limited to only information regarding the clinical indication, anticipated timelines of the trial, the number of patients dose, and such other information of a similar nature as may be reasonably required by the Third Party Licence;
5.5.3 In the event that the Company wishes to disclose the content of Progress Reports to a third party in connection with capital raising, financing, transactional, and/or licensing activities or prospects for the benefit of the Company, it shall give notice to the Charity, including details of the content of the proposed disclosure and the reason for wishing to make such disclosure, and obtain the Charity’s approval before proceeding with the disclosure. The Company shall inform Charity of the identity of the third party in its notice unless it is prevented from doing so due to express confidentiality restrictions owed to the third party, in which case the Company shall state the main business area within which the third party operates; and
5.5.4 It is further provided that any disclosure of the content of Progress Reports by the Company shall be subject to the following conditions: (a) all recipients shall be informed in writing beforehand of the confidential nature of the information being disclosed and shall have agreed in writing to obligations of confidentiality in favour of the Company no less onerous than those contained in this Clause 5 (but without any right of further disclosure) to keep such information confidential; and (b) only the content of the documents containing the relevant information which has been processed into a suitable format may be desirable or necessary disclosed but not copies of the actual documents themselves. Condition (a) above shall not apply to a disclosure by the Company for the parties purpose mentioned in Clause 5.5.2(a). Confidential treatment has been requested for certain portions of this exhibit pursuant to disclose a request for confidential treatment under Rule 24b-2 of the Exchange Act of 1934, as amended. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Confidential portions are marked: [***].
5.6 The Charity will include provisions in its contracts with the Contributor(s) that require such Contributor(s) to notify the Charity in advance of submission of any abstract, presentation or manuscript incorporating Clinical Trial Results that the Contributor(s) wish to publish or have published or to present or have presented.
5.7 Upon receipt of such notification from a Contributor or if the Charity wishes itself to publish or have published or to present or have presented an abstract, presentation or manuscript incorporating Clinical Trial Results the Charity shall so notify the Company and CRT and provide (in so far as it is able to do so in the case of a Contributor’s notification) in response to the Company’s and/or CRT’s reasonable request a copy or summary thereof at least seven (7) days prior to submission for publication of an abstract or presentation or at least thirty (30) days prior to submission for publication of a manuscript (or twenty one another certain (21) days prior to submission for publication of their a manuscript in the case of a Contributor’s notification). Any such copy or summary shall provide sufficient details to enable the Company and CRT to ascertain whether it contains Confidential InformationInformation of the Company or CRT respectively or whether Patent Rights or other proprietary protection should be sought.
5.8 The Company and CRT shall review and make any comments on such intended publication or presentation of an abstract to the Charity within seven (7) days and/or shall review and make any comments on such intended publication or presentation of a manuscript within thirty (30) days. The Company and/or CRT may request that:
5.8.1 Confidential Information of the Company (not including Clinical Trial Results nor information directly relating to the Investigational Medicinal Product) or Confidential Information of CRT (not including Clinical Trial Results) be removed from the proposed publication or presentation; and/or
5.8.2 any such publication or presentation be delayed if in the Company’s or CRT’s reasonable opinion it is necessary to delay publication or presentation in order to file a patent application or application for other proprietary protection in respect of any invention made in the course of the Clinical Trial. Any such delay will be kept to the minimum period practicable and will in no event extend beyond thirty (30) days from the date the proposed publication or presentation was provided to the Company. In the event of receipt of such Confidential Informationa request pursuant to Clauses 5.8.1 or 5.8.2, the receiving party agrees Company or CRT (as the case may be) shall provide the Charity with a written explanation of the reasons why it believes information should be removed or a delay is necessary. For the avoidance of doubt, any Patent Rights filed pursuant to preserve such Clause 5.8.2 shall be filed in CRT’s name.
5.9 The Charity and CRT shall be entitled to publish information as confidential and not to disclose it to third parties or to use it except in connection with this License Agreement for a period of seven and one-half (7.5) years after receipt. The foregoing obligations shall not apply to any information that:
(a) is now in the public domain or becomes generally available relation to the public through no fault proposed Clinical Trial, including that it is or will be a trial conducted by the Clinical Development Partnerships initiative set up by the Charity and CRT, the pre-requisites for patient recruitment, a brief description of the receiving party;
(b) is already known toClinical Trial, or in including the possession ofname of the Company, the receiving party as can be demonstrated by documentary evidence;
(c) is disclosed to the receiving party on a nonconfidential basis by a third party having the right to make such disclosure; or
(d) is independently developed by the receiving party as can be demonstrated by documentary evidence. In addition, to the extent reasonably necessary to fulfill its obligations or exercise its rights under this License Agreement (i) a party may disclose Confidential Information to its Affiliates, Sublicensees, consultants, outside contractors reference number and clinical investigators, on a need-to-know basis on condition that such persons or entities agree to be bound by the provisions of this Section 8.1, (ii) a party or its Affiliates or Sublicensees may disclose Confidential Information to governmental or other regulatory authorities to the extent that such disclosure is reasonably necessary to obtain patents or regulatory authorizations, provided the disclosing party shall request confidential treatment thereof, and (iii) a party may disclose Confidential Information as required by applicable law, regulation or judicial process, provided that such party shall give the other party (x) prior written notice thereof, (y) adequate opportunity to object to any such disclosure or to request confidential treatment thereof, and (z) shall take all steps reasonably possible to minimize the disclosure to that level mandated by law.
8.2 The parties may make a joint announcement class of the existence of this License Agreement. Licensee Investigational Medicinal Product and its Sublicensees may announce clinical, regulatory and commercial developments related to Licensed Products. Other than as described above, Southern Research Institute License Agreement 12 neither party shall publish any news release or other public announcement, written or oral, announcing this License Agreement or any performance thereunder, except to the extent required by law in location(s) at which the reasonable opinion of legal counsel for the originating party (written notice of such opinion being given to the other party prior to publication and such publication delayed for a reasonable time to allow the nonpublishing party to respond) or to the extent mutually agreed by the partiestrial is taking place.
8.3 Southern and Licensee hereby reaffirm their obligations pursuant to Section 11 of the Research Agreement.
Appears in 1 contract
Samples: Clinical Trial and Option Agreement (Asterias Biotherapeutics, Inc.)