RESPECTIVE CONTRIBUTIONS OF THE PARTIES. A. Joint Responsibilities 1. Steering Committee and Communication Plan A Steering Committee will be employed by the Parties to exchange information and data and to discuss and to plan the proposed and ongoing clinical research. The Steering Committee shall be composed of the CRADA Principal Investigators from both Parties. In addition, other NCI and Collaborator staff with expertise in toxicology, pharmacology, pharmaceutical development, project management and other disciplines, as pertinent to the current development stage of the Investigational Agent at the time of the meeting, will be participating members. Both Parties shall report regularly to the Steering Committee on the progress of the clinical research and development efforts covered by this CRADA, will review the current progress, and will make any required decisions. The routes of communication, format of written minutes, etc. will be determined at the Steering Committee meetings and will be driven by the needs of the project. The Steering Committee will function under the oversight of Co-Chairs, one from NCI and one from the Collaborator. NCI’s Steering Committee Co-Chair will be appointed by the DCTD Division Director and report to the DCTD Division Director or his or her designee. Steering Committee meeting minutes summarizing all key decisions and issues under discussion will be provided to all the Steering Committee members and to the DCTD Division Director within ten (10) days of each meeting. Steering Committee decisions will be made by consensus. In addition to the Steering Committee, a Project Team comprised of NCI and Collaborator scientific members will be assembled for the purpose of discussing the DCTD Clinical Support Assays. This Project Team will be a collaborative body to approve projects described in Section 5C1 of this Appendix A which outlines the DCTD Clinical Support Assays. This Project Team will be a collaborative body charged with the planning and successful execution of experimental objectives. It is intended that study areas approved by the Project Team will be broad enough in scope to allow all necessary experiments to realize the goal of said research without further approval from the Project Team. Submission of new projects/areas of inquiry will be addressed by the Project Teams within seven (7) days of receipt. Disagreements between DCTD and Collaborator will be discussed by the Steering Committee and/or Project Team who may recommend a course of action. In the event that Project Team is unable to reach consensus, it will be the Division Director’s responsibility to resolve any Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A impasse. The Division Director will confer with representatives of the Collaborator before making any decision. Project Teams will meet quarterly, or more often if necessitated by results or submission of a new project/area of inquiry. 2. The DCTD and Collaborator will explore the clinical utility of Investigational Agent for various cancers. As sensitive tumor types are identified, it will be important to develop combinations of Investigational Agent and other active anti-cancer agents and to compare Investigational Agent and Investigational Agent combinations with standard therapy for these tumor types. Adjuvant studies may be important in diseases where Investigational Agent has activity and where there is a high risk of recurrence following initial primary therapy. 3. Both Parties shall collaborate in the collection and analysis of data generated under the Research Plan. 4. Both Parties will work closely together to ensure that the clinical studies move forward expeditiously. B. Collaborator Responsibilities C. DCTD Responsibilities 1. […***…] Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A […***…] Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A […***…] 5. Investigational Drug Steering Committee (IDSC) The NCI Clinical Trials Working Group has mandated the formation of the Investigational Drug Steering Committee (IDSC). The IDSC is designed to provide DCTD with broad external scientific and clinical input for the design and prioritization of phase 1 and phase 2 trials with agents for which CTEP sponsors an IND. Membership of the IDSC includes the principal investigators of phase 1 U01 grants and phase 2 N01 contracts, representatives from the NCI Cooperative Groups, NCI staff members, and additional representatives with expertise in biostatistics, correlative science technologies, radiation oncology, etc., as well as patient advocates and community oncologists, as needed. Experts with specific expertise will be included as ad hoc members for consideration of specific agents. Periodically, the IDSC will assess, from a strategic perspective, CTEP investigational agent development plans, agent portfolios, and XXXx submitted by investigators to determine whether the clinical development plan for an agent should be modified. When requested by CTEP, the IDSC will provide input on XXXx to assist in CTEP decision-making. All participating members will be vetted for conflict of interest and are under confidentiality agreements with DCTD. The IDS C is described in greater detail on p. 23 of the report of the Cancer Trials Working Group of National Cancer Advisory Board (xxxx://xxxxxxxxxxxxxxxx.xxx.xxx.xxx/ict/CTWG_report_June2005.pdf) Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A
Appears in 2 contracts
Samples: Cooperative Research and Development Agreement (Tracon Pharmaceuticals, Inc.), Cooperative Research and Development Agreement (Tracon Pharmaceuticals Inc)
RESPECTIVE CONTRIBUTIONS OF THE PARTIES. A. Joint Responsibilities
1. Steering Committee and Communication Plan A Steering Committee will be employed by the Parties to exchange information and data and to discuss and to plan the proposed and ongoing clinical research. The Steering Committee shall be composed comprised of at least the NIH CRADA Extramural Investigator/Officer(s) and the CRADA Principal Investigators Collaborator PI from both Parties. In additionaddition , other NCI and Collaborator staff with expertise in toxicology, pharmacology, pharmaceutical development, project management and other disciplines, disciplines as pertinent to the current development stage of the Investigational Agent at the time of the meeting, meeting will be participating members. Both Parties shall report regularly to the Steering Committee on the progress of the clinical research and development efforts covered by this CRADA, will review the current progress, and will make any required decisions. The routes of communication, format of written minutes, etc. will be determined at the Steering Committee meetings and will be driven by the needs of the project. The Steering Committee will function under the oversight of Co-Chairs, one from NCI and one from the Collaborator. NCI’s Steering Committee Co-Chair will be appointed by the DCTD Division Director and report to the DCTD Division Director or his or her designee. Steering Committee meeting minutes summarizing all key decisions and issues under discussion will be provided to all the Steering Committee members and to the DCTD Division Director within ten (10) days of each meeting. Steering Committee decisions will be made by consensus. In addition to the Steering Committee, Committee a Project Team comprised of NCI and Collaborator scientific members will be assembled for the purpose of discussing the DCTD Clinical Support Assays. This Project Team will be a collaborative body to approve projects described in Section 5C1 of this Appendix A which outlines the DCTD Clinical Support Assays. This Project Team will be a collaborative body charged with the planning and successful execution of experimental objectives. It is intended that study areas approved by the Project Team will be broad enough in scope to allow all necessary experiments to realize the goal of said research without further approval from the Project Team. Submission of new projects/areas of inquiry will be addressed by the Project Teams within seven (7) days of receipt. Disagreements between DCTD and Collaborator will be discussed by the Steering Committee and/or Project Team who may recommend a course of action. In the event that Project Team is unable to reach consensus, it will be the Division Director’s responsibility to resolve any Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A impasse. The Division Director will confer with representatives of the Collaborator before making any decision. Project Teams will meet quarterly, or more often if necessitated by results or submission of a new projectprojects/area of inquiry.
2. The DCTD and Collaborator will explore the clinical utility of Investigational Agent for various cancers. As sensitive tumor types are identified, it will be Confidential NCI - Tracon CRADA (CACR 12-1-00012), Appendix A important to develop combinations of Investigational Agent and other active anti-cancer agents and to compare Investigational Agent and Investigational Agent combinations with standard therapy for these tumor types. Adjuvant studies may be important in diseases where Investigational Agent has activity and where there is a high risk of recurrence following initial primary therapy.
3. Both Parties shall collaborate in the collection and analysis of data generated under the Research Plan.
4. Both Parties will work closely together to ensure that the clinical studies move forward expeditiously.
B. Collaborator Responsibilities
C. DCTD Responsibilities
1. […***…] Confidential NCI – - Tracon CRADA (NCI# 02663), Appendix A […***…] Confidential NCI – Tracon CRADA (NCI# 02663CACR 12-1-00012), Appendix A […***…]
5. Investigational Drug Steering Committee (IDSC) The NCI Clinical Trials Working Group has mandated the formation of the Investigational Drug Steering Committee (IDSC). The IDSC is designed to provide DCTD with broad external scientific and clinical input for the design and prioritization of phase 1 and phase 2 trials with agents for which CTEP sponsors an IND. Membership of the IDSC includes the principal investigators of phase 1 U01 grants and phase 2 N01 contracts, representatives from the NCI Cooperative Groups, NCI staff members, and additional representatives with expertise in biostatistics, correlative science technologies, radiation oncology, etc., as well as patient advocates and community oncologists, as needed. Experts with specific expertise will be included as ad hoc members for consideration of specific agents. Periodically, the IDSC will assess, from a strategic perspective, CTEP investigational agent development plans, agent portfolios, and XXXx submitted by investigators to determine whether the clinical development plan for an agent should be modified. When requested by CTEP, the IDSC will provide input on XXXx to assist in CTEP decision-making. All participating members will be vetted for conflict of interest and are under confidentiality agreements with DCTD. The IDS C is described in greater detail on p. 23 of the report of the Cancer Trials Working Group of National Cancer Advisory Board (xxxx://xxxxxxxxxxxxxxxx.xxx.xxx.xxx/ict/CTWG_report_June2005.pdf) Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A
Appears in 2 contracts
Samples: Cooperative Research and Development Agreement (Tracon Pharmaceuticals, Inc.), Cooperative Research and Development Agreement (Tracon Pharmaceuticals Inc)
RESPECTIVE CONTRIBUTIONS OF THE PARTIES. A. Joint Responsibilities
1. Steering Committee and Communication Plan A Steering Committee will be employed by the Parties to exchange information and data and to discuss and to plan the proposed and ongoing clinical research. The Steering Committee shall be composed of the CRADA Principal Investigators from both PartiesNCI and NewLink. In addition, other NCI and Collaborator NewLink staff with expertise in toxicology, pharmacology, pharmaceutical development, project management and other disciplines, disciplines as pertinent to the current development stage of the Investigational Agent at the time of a meeting may participate in the meeting, will be participating membersmeetings of the Steering Committee. Both Parties shall report regularly to the Steering Committee on the progress of the clinical research and development efforts covered by this CRADA, will review the current progress, and will make any required decisions. The routes of communication, format of written minutes, etc. will be determined at the Steering Committee meetings and will be driven by the needs of the project. The Parties have been meeting regularly prior to the execution of this CRADA Letter of Intent, and will continue to do so. The Steering Committee will function under the oversight of Co-Chairs, one from NCI and one from the Collaborator. NCI’s Steering Committee Co-Chair will be appointed by the DCTD Division Director and report to the DCTD Division Director or his or her designee. Steering Committee meeting minutes summarizing all key decisions and issues under discussion will be provided to all the Steering Committee members and to the DCTD Division Director within ten (10) days [*] of each meeting. Steering Committee decisions will be made by consensus. In addition to the Steering Committee, a Project Team comprised of NCI and Collaborator scientific members will be assembled for the purpose of discussing the DCTD Clinical Support Assays. This Project Team will be a collaborative body to approve projects described in Section 5C1 of this Appendix A which outlines the DCTD Clinical Support Assays. This Project Team will be a collaborative body charged with the planning and successful execution of experimental objectives. It is intended that study areas approved by the Project Team will be broad enough in scope to allow all necessary experiments to realize the goal of said research without further approval from the Project Team. Submission of new projects/areas of inquiry will be addressed by the Project Teams within seven (7) days of receipt. Disagreements between DCTD and Collaborator will be discussed by the Steering Committee and/or Project Team who may recommend a course of action. In the event that Project Team is unable to reach consensus, it will be the Division Director’s responsibility to resolve any Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A impasse. The Division Director will confer with representatives of the Collaborator before making any decision. Project Teams will meet quarterly, or more often if necessitated by results or submission of a new project/area of inquiry[*].
2. DCTD’s preclinical and ancillary studies shall be conducted [*], as per [*].
3. The DCTD and Collaborator NewLink will explore the clinical utility of Investigational Agent [*] for various cancers[*]. As sensitive tumor types [*] are identified, it will be important to develop combinations of Investigational Agent [*] and other active anti-cancer agents [*] and to compare Investigational Agent [*] and Investigational Agent combinations [*] with standard therapy [*] for these tumor types. Adjuvant [*].[*] studies may be important in diseases where Investigational Agent has activity [*] and where there is a high risk of recurrence [*] following initial primary therapy[*].
34. Both Parties shall collaborate in the collection and analysis of data generated under the Research Plan.
45. Both Parties will work closely together to ensure that the pre-clinical and clinical studies move forward expeditiously.
6. Subject to the obligations of the Parties to maintain the data under this CRADA as confidential and proprietary, the Parties may publicly disclose the results of their research under the circumstances set forth in the model CRADA.
7. When pre-clinical studies and/or a CRADA clinical protocol involves either [*] or involves [*], the NCI, NewLink [*] will jointly determine a reasonable and appropriate mechanism for intellectual property and data access and sharing prior to initiation of the pre-clinical studies and/or the clinical trial.
8. For activities conducted pursuant to this CRADA in the United States of America, both Parties agree to comply with all appropriate DHHS regulations relating to Human Subjects Use, all U.S. Department of Agriculture regulations, and all Public Health Service policies relating to the use and care of laboratory animals. For activities conducted pursuant to this CRADA outside of the United States of America, both Parties shall conduct such in accordance with GLPs and all applicable rules, regulations and statutes, both local and national, governing such activity in that country.
9. The Parties acknowledge that [*] means any [*] that is either readily usable as a [*] or is [*] that will be useful to [*] in developing [*] (rather than useful [*] or [*]). A [*] may simultaneously be a [*] and be the essence of a [*], or [*] (or an integral component of such [*]). For the purposes of this CRADA, [*] shall include, but not be limited to, a [*]. If NewLink elects to request [*] that is a [*], such [*] will ensure, as appropriate for the circumstances, that (a) the [*] will undertake to make the [*] on a [*] to [*] for [*] under [*], such [*], or (b) [*] the right to make the [*] on a [*] to [*] for [*] purposes under [*].
B. Collaborator Responsibilities
C. DCTD NewLink Responsibilities
1. Following execution of the CRADA, […*] will provide [*] funding for pre-clinical studies including the IND-directed toxicity studies and formulation studies which will be conducted by [*…]. The exact amount of funding and the payment schedule will be agreed upon and addressed in an Appendix B to the executed CRADA.
2. Following CRADA execution, [*] will be responsible for the [*] cost of GMP-grade [*] in current [*] inventories manufactured to support pre-clinical studies, NCI-sponsored [*] clinical trials, and NewLink-sponsored [*] clinical trials. The exact amount of funding and the payment schedule will be agreed upon and addressed in an Appendix B to the executed CRADA. If additional formulated [*] is required for clinical studies under this CRADA Research Plan, [*] will be responsible for the provision and costs of such extra supply of formulated and acceptably labeled [*].[*] may elect to produce bulk [*] and formulated [*] through contractors other than established [*] contractors in order to obtain the most competitive pricing. [*] will then be responsible for subsequent payment of such contractors, and [*] will have no obligations with respect to such contractors. If [*] elects to perform any portion of this CRADA Research Plan through a contractor or consultant, [*] shall incorporate into such contracts all provisions necessary to ensure that the work of the contractor or consultant is governed by the terms of the CRADA, including, but not limited to, a provision for the assignment of inventions of the contractor or consultant to [*]; such inventions shall be deemed [*] of [*]. In addition, [*] will ensure that any contractor or consultant is obligated to maintain [*] Confidential Information regarding [*] manufacturing and formulation in confidence at least to the extent provided for by the terms of the CRADA. Following the use of [*] supplies of [*],[*] will provide [*] to [*] for use by [*] in [*] studies, studies designed to [*], and other studies relevant to the development of [*] as provided in the Research Plan.
3. NewLink will prepare and submit to the FDA an Investigational New Drug Application (IND) for NewLink sponsored clinical studies of [*], which will cross-reference the DCTD IND.
4. NewLink agrees to permit DCTD to supply formulated [*] for all clinical trials set forth in this CRADA. This includes: · Provision of appropriately packaged and labeled [*] for all NCI-sponsored clinical studies; · Supply of [*] for compassionate use, as described in the NCI – Tracon CRADA (NCI# 02663)Investigator Handbook; and · Supply of [*] for, Appendix A and any resources necessary for the management of, Group C distribution, as described in the NCI Investigator Handbook. Group C distribution shall be initiated if such action is justified by clinical results and is feasible based on adequate […*] supply, such that NewLink’s NDA efforts are not negatively impacted. NewLink agrees to supply [*], or to provide unformulated analytical grade [*…] Confidential NCI – Tracon CRADA (NCI# 02663)or metabolites, Appendix A if available, to DCTD for DCTD to provide to DCTD intramural and extramural investigators for the development of analytical assays or ancillary correlative studies conducted in conjunction with DCTD-approved protocols. NewLink also agrees to provide […*] for distribution for pre-clinical studies designed to [*]. These will include pre-clinical studies designed to support clinical trials in [*…]; pre-clinical [*] studies to provide data in support of a clinical trial; and other pertinent requests.
5. Investigational Drug Steering Committee (IDSC) The NCI Clinical Trials Working Group has mandated Upon CRADA execution, NewLink will provide resources for data collection and management, beyond that normally carried out by the formation DCTD as set forth in the CRADA for CTEP-sponsored studies, if NewLink desires such data collection and management. This would include the collection of the Investigational Drug Steering Committee (IDSC)data required to submit an NDA to the FDA.
6. The IDSC is designed Upon CRADA execution, NewLink may provide funds for partial support of the DCTD-sponsored clinical trials and IND.
7. Upon CRADA execution, NewLink will provide funds for travel by DCTD staff to provide DCTD attend meetings sponsored by NewLink concerning [*] clinical trials, such funds not to exceed [*] per year of the term of the CRADA.
8. NewLink intends and will use reasonable efforts to prepare and submit an NDA to the FDA expeditiously when justified by clinical studies, with broad external scientific and clinical input the object of obtaining pharmaceutical regulatory approval for the design commercial marketing of [*].
9. NewLink may sponsor its own clinical trials using [*]. Such Collaborator-sponsored trials are outside the scope of this CRADA. For these clinical trials, NewLink will maintain possession and prioritization of phase 1 and phase 2 trials with agents for which CTEP sponsors an IND. Membership control of the IDSC includes clinical trial results. NewLink will permit DCTD to review and use the principal investigators of phase 1 U01 grants and phase 2 N01 contracts, representatives from the NCI Cooperative Groups, NCI staff members, and additional representatives with expertise in biostatistics, correlative science technologies, radiation oncology, etc., as well as patient advocates and community oncologists, as needed. Experts with specific expertise will be included as ad hoc members results for consideration of specific agents. Periodically, the IDSC will assess, from a strategic perspective, CTEP investigational agent development plans, agent portfolios, and XXXx submitted by investigators to determine whether the DCTD-sponsored clinical development plan for an agent should be modified. When requested by CTEP, the IDSC will provide input on XXXx to assist in CTEP decision-making. All participating members will be vetted for conflict of interest and trials which are under confidentiality agreements with DCTDthe CRADA.
10. The IDS C is described in greater detail NewLink will update DCTD on p. 23 the progress of the report its preclinical studies of the Cancer Trials Working Group of National Cancer Advisory Board (xxxx://xxxxxxxxxxxxxxxx.xxx.xxx.xxx/ict/CTWG_report_June2005.pdf) Confidential [*] to help ensure optimal experimental designs and avoid duplication.
C. NCI – Tracon CRADA (NCI# 02663), Appendix AResponsibilities
Appears in 2 contracts
Samples: Cooperative Research and Development Agreement (Newlink Genetics Corp), Cooperative Research and Development Agreement (Newlink Genetics Corp)
RESPECTIVE CONTRIBUTIONS OF THE PARTIES. A. Joint Responsibilities
1. Steering Committee and Communication Plan A Steering Committee will be employed by the Parties to exchange information and data and to discuss and to plan the proposed and ongoing clinical research. The Steering Committee shall be composed of the CRADA Principal Investigators from both PartiesNCI and NewLink. In addition, other NCI and Collaborator NewLink staff with expertise in toxicology, pharmacology, pharmaceutical development, project management and other disciplines, disciplines as pertinent to the current development stage of the Investigational Agent at the time of a meeting may participate in the meeting, will be participating membersmeetings of the Steering Committee. Both Parties shall report regularly to the Steering Committee on the progress of the clinical research and development efforts covered by this CRADA, will review the current progress, and will make any required decisions. The routes of communication, format of written minutes, etc. will be determined at the Steering Committee meetings and will be driven by the needs of the project. The Parties have been meeting regularly prior to the execution of this CRADA Letter of Intent, and will continue to do so. The Steering Committee will function under the oversight of Co-Chairs, one from NCI and one from the Collaborator. NCI’s Steering Committee Co-Chair will be appointed by the DCTD Division Director and report to the DCTD Division Director or his or her designee. Steering Committee meeting minutes summarizing all key decisions and issues under discussion will be provided to all the Steering Committee members and to the DCTD Division Director within ten (10) days [*] of each meeting. Steering Committee decisions will be made by consensus. In addition to the Steering Committee, a Project Team comprised of NCI and Collaborator scientific members will be assembled for the purpose of discussing the DCTD Clinical Support Assays. This Project Team will be a collaborative body to approve projects described in Section 5C1 of this Appendix A which outlines the DCTD Clinical Support Assays. This Project Team will be a collaborative body charged with the planning and successful execution of experimental objectives. It is intended that study areas approved by the Project Team will be broad enough in scope to allow all necessary experiments to realize the goal of said research without further approval from the Project Team. Submission of new projects/areas of inquiry will be addressed by the Project Teams within seven (7) days of receipt. Disagreements between DCTD and Collaborator will be discussed by the Steering Committee and/or Project Team who may recommend a course of action. In the event that Project Team is unable to reach consensus, it will be the Division Director’s responsibility to resolve any Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A impasse. The Division Director will confer with representatives of the Collaborator before making any decision. Project Teams will meet quarterly, or more often if necessitated by results or submission of a new project/area of inquiry[*].
2. DCTD’s preclinical and ancillary studies shall be conducted [*], as per [*].
3. The DCTD and Collaborator NewLink will explore the clinical utility of Investigational Agent 1MT for various cancers. As sensitive tumor types are identified, it will be important to develop combinations of Investigational Agent 1MT and other active anti-cancer agents and to compare Investigational Agent 1MT and Investigational Agent 1MT combinations with standard therapy for these tumor types. Adjuvant studies may be important in diseases where Investigational Agent 1MT has activity and where there is a high risk of recurrence following initial primary therapy.
34. Both Parties shall collaborate in the collection and analysis of data generated under the Research Plan.
45. Both Parties will work closely together to ensure that the pre-clinical and clinical studies move forward expeditiously.
6. Subject to the obligations of the Parties to maintain the data under this CRADA as confidential and proprietary, the Parties may publicly disclose the results of their research under the circumstances set forth in the model CRADA.
7. When pre-clinical studies and/or a CRADA clinical protocol involves either [*] or involves [*], the NCI, NewLink [*] will jointly determine a reasonable and appropriate mechanism for intellectual property and data access and sharing prior to initiation of the pre-clinical studies and/or the clinical trial.
8. For activities conducted pursuant to this CRADA in the United States of America, both Parties agree to comply with all appropriate DHHS regulations relating to Human Subjects Use, all U.S. Department of Agriculture regulations, and all Public Health Service policies relating to the use and care of laboratory animals. For activities conducted pursuant to this CRADA outside of the United States of America, both Parties shall conduct such in accordance with GLPs and all applicable rules, regulations and statutes, both local and national, governing such activity in that country.
9. The Parties acknowledge that [*] means any [*] that is either readily usable as a [*] or is [*] that will be useful to [*] in developing [*] (rather than useful [*] or [*]). A [*] may simultaneously be a [*] and be the essence of a [*], or [*] (or an integral component of such [*]). For the purposes of this CRADA, [*] shall include, but not be limited to, a [*]. If NewLink elects to request [*] that is a [*], such [*] will ensure, as appropriate for the circumstances, that (a) the [*] will undertake to make the [*] on a [*] to [*] for [*] under [*], such [*], or (b) [*] the right to make the [*] on a [*] to [*] for [*] purposes under [*].
B. Collaborator Responsibilities
C. DCTD NewLink Responsibilities
1. Following execution of the CRADA, NewLink will provide […*] funding for pre-clinical studies including the IND-directed toxicity studies and formulation studies which will be conducted by [*]. The exact amount of funding and the payment schedule will be agreed upon and addressed in an Appendix B to the executed CRADA.
2. Following CRADA execution, NewLink will be responsible for the [*…] cost of GMP-grade 1MT in current [*] inventories manufactured to support pre-clinical studies, NCI-sponsored [*] clinical trials, and NewLink-sponsored [*] clinical trials. The exact amount of funding and the payment schedule will be agreed upon and addressed in an Appendix B to the executed CRADA. If additional formulated 1MT is required for clinical studies under this CRADA Research Plan, NewLink will be responsible for the provision and costs of such extra supply of formulated and acceptably labeled 1MT. NewLink may elect to produce bulk 1MT and formulated 1MT through contractors other than established [*] contractors in order to obtain the most competitive pricing. NewLink will then be responsible for subsequent payment of such contractors, and [*] will have no obligations with respect to such contractors. If NewLink elects to perform any portion of this CRADA Research Plan through a contractor or consultant, NewLink shall incorporate into such contracts all provisions necessary to ensure that the work of the contractor or consultant is governed by the terms of the CRADA, including, but not limited to, a provision for the assignment of inventions of the contractor or consultant to NewLink; such inventions shall be deemed [*] of NewLink. In addition, NewLink will ensure that any contractor or consultant is obligated to maintain [*] Confidential Information regarding 1MT manufacturing and formulation in confidence at least to the extent provided for by the terms of the CRADA. Following the use of [*] supplies of 1MT, NewLink will provide 1MT to [*] for use by [*] in [*] studies, studies designed to [*] of 1MT, and other studies relevant to the development of 1MT as provided in the Research Plan.
3. NewLink will prepare and submit to the FDA an Investigational New Drug Application (IND) for NewLink sponsored clinical studies of 1MT, which will cross-reference the DCTD IND.
4. NewLink agrees to permit DCTD to supply formulated 1MT for all clinical trials set forth in this CRADA. This includes: · Provision of appropriately packaged and labeled 1MT for all NCI-sponsored clinical studies; · Supply of 1MT for compassionate use, as described in the NCI – Tracon CRADA (NCI# 02663)Investigator Handbook; and · Supply of 1MT for, Appendix A and any resources necessary for the management of, Group C distribution, as described in the NCI Investigator Handbook. Group C distribution shall be initiated if such action is justified by clinical results and is feasible based on adequate 1MT supply, such that NewLink’s NDA efforts are not negatively impacted. NewLink agrees to supply 1MT, or to provide unformulated analytical grade 1MT or metabolites, if available, to DCTD for DCTD to provide to DCTD intramural and extramural investigators for the development of analytical assays or ancillary correlative studies conducted in conjunction with DCTD-approved protocols. NewLink also agrees to provide 1MT for distribution for pre-clinical studies designed to enhance the basic understanding and development of 1MT. These will include pre-clinical studies designed to support clinical trials in […*]; pre-clinical [**…] Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A […***…]studies to provide data in support of a clinical trial; and other pertinent requests.
5. Investigational Drug Steering Committee (IDSC) The NCI Clinical Trials Working Group has mandated Upon CRADA execution, NewLink will provide resources for data collection and management, beyond that normally carried out by the formation DCTD as set forth in the CRADA for CTEP-sponsored studies, if NewLink desires such data collection and management. This would include the collection of the Investigational Drug Steering Committee (IDSC)data required to submit an NDA to the FDA.
6. The IDSC is designed Upon CRADA execution, NewLink may provide funds for partial support of the DCTD-sponsored clinical trials and IND.
7. Upon CRADA execution, NewLink will provide funds for travel by DCTD staff to provide DCTD attend meetings sponsored by NewLink concerning 1MT clinical trials, such funds not to exceed [*] per year of the term of the CRADA.
8. NewLink intends and will use reasonable efforts to prepare and submit an NDA to the FDA expeditiously when justified by clinical studies, with broad external scientific and clinical input the object of obtaining pharmaceutical regulatory approval for the design commercial marketing of 1MT.
9. NewLink may sponsor its own clinical trials using 1MT. Such Collaborator-sponsored trials are outside the scope of this CRADA. For these clinical trials, NewLink will maintain possession and prioritization of phase 1 and phase 2 trials with agents for which CTEP sponsors an IND. Membership control of the IDSC includes clinical trial results. NewLink will permit DCTD to review and use the principal investigators of phase 1 U01 grants and phase 2 N01 contracts, representatives from the NCI Cooperative Groups, NCI staff members, and additional representatives with expertise in biostatistics, correlative science technologies, radiation oncology, etc., as well as patient advocates and community oncologists, as needed. Experts with specific expertise will be included as ad hoc members results for consideration of specific agents. Periodically, the IDSC will assess, from a strategic perspective, CTEP investigational agent development plans, agent portfolios, and XXXx submitted by investigators to determine whether the DCTD-sponsored clinical development plan for an agent should be modified. When requested by CTEP, the IDSC will provide input on XXXx to assist in CTEP decision-making. All participating members will be vetted for conflict of interest and trials which are under confidentiality agreements with DCTDthe CRADA.
10. The IDS C is described in greater detail NewLink will update DCTD on p. 23 the progress of the report its preclinical studies of the Cancer Trials Working Group of National Cancer Advisory Board (xxxx://xxxxxxxxxxxxxxxx.xxx.xxx.xxx/ict/CTWG_report_June2005.pdf) Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A1MT to help ensure optimal experimental designs and avoid duplication.
Appears in 1 contract
Samples: Cooperative Research and Development Agreement (Newlink Genetics Corp)
RESPECTIVE CONTRIBUTIONS OF THE PARTIES. A. Joint Responsibilities
1. Steering Committee and Communication Plan A Steering Committee will be employed by the Parties to exchange information and data and to discuss and to plan the proposed and ongoing clinical research. The Steering Committee shall be composed comprised of at least the NIH CRADA Extramural Investigator/Officer(s) and the CRADA Principal Investigators Collaborator PI from both Parties. In additionaddition , other NCI and Collaborator staff with expertise in toxicology, pharmacology, pharmaceutical development, project management and other disciplines, disciplines as pertinent to the current development stage of the Investigational Agent at the time of the meeting, meeting will be participating members. Both Parties shall report regularly to the Steering Committee on the progress of the clinical research and development efforts covered by this CRADA, will review the current progress, and will make any required decisions. The routes of communication, format of written minutes, etc. will be determined at the Steering Committee meetings and will be driven by the needs of the project. The Steering Committee will function under the oversight of Co-Chairs, one from NCI and one from the Collaborator. NCI’s Steering Committee Co-Chair will be appointed by the DCTD Division Director and report to the DCTD Division Director or his or her designee. Steering Committee meeting minutes summarizing all key decisions and issues under discussion will be provided to all the Steering Committee members and to the DCTD Division Director within ten (10) days of each meeting. Steering Committee decisions will be made by consensus. In addition to the Steering Committee, Committee a Project Team comprised of NCI and Collaborator scientific members will be assembled for the purpose of discussing the DCTD Clinical Support Assays. This Project Team will be a collaborative body to approve projects described in Section 5C1 of this Appendix A which outlines the DCTD Clinical Support Assays. This Project Team will be a collaborative body charged with the planning and successful execution of experimental objectives. It is intended that study areas approved by the Project Team will be broad enough in scope to allow all necessary experiments to realize the goal of said research without further approval from the Project Team. Submission of new projects/areas of inquiry will be addressed by the Project Teams within seven (7) days of receipt. Disagreements between DCTD and Collaborator will be discussed by the Steering Committee and/or Project Team who may recommend a course of action. In the event that Project Team is unable to reach consensus, it will be the Division Director’s responsibility to resolve any Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A impasse. The Division Director will confer with representatives of the Collaborator before making any decision. Project Teams will meet quarterly, or more often if necessitated by results or submission of a new projectprojects/area of inquiry.
2. The DCTD and Collaborator will explore the clinical utility of Investigational Agent for various cancers. As sensitive tumor types are identified, it will be Confidential NCI - Tracon CRADA (CACR 12-1-00012), Appendix A important to develop combinations of Investigational Agent and other active anti-cancer agents and to compare Investigational Agent and Investigational Agent combinations with standard therapy for these tumor types. Adjuvant studies may be important in diseases where Investigational Agent has activity and where there is a high risk of recurrence following initial primary therapy.
3. Both Parties shall collaborate in the collection and analysis of data generated under the Research Plan.
4. Both Parties will work closely together to ensure that the clinical studies move forward expeditiously.
B. Collaborator ResponsibilitiesResponsibilities […***…] ***Confidential Treatment Requested A-5 Confidential NCI - Tracon CRADA (CACR 12-1-00012), Appendix A […***…]
C. DCTD Responsibilities
1. […***…] ***Confidential Treatment Requested A-6 Confidential NCI – - Tracon CRADA (NCI# 02663), Appendix A […***…] Confidential NCI – Tracon CRADA (NCI# 02663CACR 12-1-00012), Appendix A […***…]
5. Investigational Drug Steering Committee (IDSC) The NCI Clinical Trials Working Group has mandated the formation of the Investigational Drug Steering Committee (IDSC). The IDSC is designed to provide DCTD with broad external scientific and clinical input for the design and prioritization of phase 1 and phase 2 trials with agents for which CTEP sponsors an IND. Membership of the IDSC includes the principal investigators of phase 1 U01 grants and phase 2 N01 contracts, representatives from the NCI Cooperative Groups, NCI staff members, and additional representatives with expertise in biostatistics, correlative science technologies, radiation oncology, etc., as well as patient advocates and community oncologists, as needed. Experts with specific expertise will be included as ad hoc members for consideration of specific agents. Periodically, the IDSC will assess, from a strategic perspective, CTEP investigational agent development plans, agent portfolios, and XXXx submitted by investigators to determine whether the clinical development plan for an agent should be modified. When requested by CTEP, the IDSC will provide input on XXXx to assist in CTEP decision-making. All participating members will be vetted for conflict of interest and are under confidentiality agreements with DCTD. The IDS C is described in greater detail on p. 23 of the report of the Cancer Trials Working Group of National Cancer Advisory Board (xxxx://xxxxxxxxxxxxxxxx.xxx.xxx.xxx/ict/CTWG_report_June2005.pdf) Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A
Appears in 1 contract
RESPECTIVE CONTRIBUTIONS OF THE PARTIES. A. Joint Responsibilities
1. Steering Committee and Communication Plan A Steering Committee will be employed by the Parties to exchange information and data and to discuss and to plan the proposed and ongoing clinical research. The Steering Committee shall be composed of the CRADA Principal Investigators from both PartiesNCI and NewLink. In addition, other NCI and Collaborator NewLink staff with expertise in toxicology, pharmacology, pharmaceutical development, project management and other disciplines, disciplines as pertinent to the current development stage of the Investigational Agent at the time of a meeting may participate in the meeting, will be participating membersmeetings of the Steering Committee. Both Parties shall report regularly to the Steering Committee on the progress of the clinical research and development efforts covered by this CRADA, will review the current progress, and will make any required decisions. The routes of communication, format of written minutes, etc. will be determined at the Steering Committee meetings and will be driven by the needs of the project. The Parties have been meeting regularly prior to the execution of this CRADA Letter of Intent, and will continue to do so. The Steering Committee will function under the oversight of Co-Chairs, one from NCI and one from the Collaborator. NCI’s Steering Committee Co-Chair will be appointed by the DCTD Division Director and report to the DCTD Division Director or his or her designee. Steering Committee meeting minutes summarizing all key decisions and issues under discussion will be provided to all the Steering Committee members and to the DCTD Division Director within ten (10) days [*] of each meeting. Steering Committee decisions will be made by consensus. In addition to the Steering Committee, a Project Team comprised of NCI and Collaborator scientific members will be assembled for the purpose of discussing the DCTD Clinical Support Assays. This Project Team will be a collaborative body to approve projects described in Section 5C1 of this Appendix A which outlines the DCTD Clinical Support Assays. This Project Team will be a collaborative body charged with the planning and successful execution of experimental objectives. It is intended that study areas approved by the Project Team will be broad enough in scope to allow all necessary experiments to realize the goal of said research without further approval from the Project Team. Submission of new projects/areas of inquiry will be addressed by the Project Teams within seven (7) days of receipt. Disagreements between DCTD and Collaborator will be discussed by the Steering Committee and/or Project Team who may recommend a course of action. In the event that Project Team is unable to reach consensus, it will be the Division Director’s responsibility to resolve any Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A impasse. The Division Director will confer with representatives of the Collaborator before making any decision. Project Teams will meet quarterly, or more often if necessitated by results or submission of a new project/area of inquiry[*].
2. DCTD’s preclinical and ancillary studies shall be conducted [*], as per [*].
3. The DCTD and Collaborator NewLink will explore the clinical utility of Investigational Agent 1MT for various cancers. As sensitive tumor types are identified, it will be important to develop combinations of Investigational Agent 1MT and other active anti-cancer agents and to compare Investigational Agent 1MT and Investigational Agent 1MT combinations with standard therapy for these tumor types. Adjuvant studies may be important in diseases where Investigational Agent 1MT has activity and where there is a high risk of recurrence following initial primary therapy.
34. Both Parties shall collaborate in the collection and analysis of data generated under the Research Plan.
45. Both Parties will work closely together to ensure that the pre-clinical and clinical studies move forward expeditiously.
6. Subject to the obligations of the Parties to maintain the data under this CRADA as confidential and proprietary, the Parties may publicly disclose the results of their research under the circumstances set forth in the model CRADA.
7. When pre-clinical studies and/or a CRADA clinical protocol involves either [*] or involves [*], the NCI, NewLink [*] will jointly determine a reasonable and appropriate mechanism for intellectual property and data access and sharing prior to initiation of the pre-clinical studies and/or the clinical trial.
8. For activities conducted pursuant to this CRADA in the United States of America, both Parties agree to comply with all appropriate DHHS regulations relating to Human Subjects Use, all U.S. Department of Agriculture regulations, and all Public Health Service policies relating to the use and care of laboratory animals. For activities conducted pursuant to this CRADA outside of the United States of America, both Parties shall conduct such in accordance with GLPs and all applicable rules, regulations and statutes, both local and national, governing such activity in that country.
9. The Parties acknowledge that [*] means any [*] that is either readily usable as a [*] or is [*] that will be useful to [*] in developing [*] (rather than useful [*] or [*]). A [*] may simultaneously be a [*] and be the essence of a [*], or [*] (or an integral component of such [*]). For the purposes of this CRADA, [*] shall include, but not be limited to, a [*]. If NewLink elects to request [*] that is a [*], such [*] will ensure, as appropriate for the circumstances, that (a) the [*] will undertake to make the [*] on a [*] to [*] for [*] under [*], such [*], or (b) [*] the right to make the [*] on a [*] to [*] for [*] purposes under [*].
B. Collaborator Responsibilities
C. DCTD NewLink Responsibilities
1. Following execution of the CRADA, NewLink will provide […*] funding for pre-clinical studies including the IND-directed toxicity studies and formulation studies which will be conducted by [*]. The exact amount of funding and the payment schedule will be agreed upon and addressed in an Appendix B to the executed CRADA.
2. Following CRADA execution, NewLink will be responsible for the [*…] cost of GMP-grade 1MT in current [*] inventories manufactured to support pre-clinical studies, NCI-sponsored [*] clinical trials, and NewLink-sponsored [*] clinical trials. The exact amount of funding and the payment schedule will be agreed upon and addressed in an Appendix B to the executed CRADA. If additional formulated 1MT is required for clinical studies under this CRADA Research Plan, NewLink will be responsible for the provision and costs of such extra supply of formulated and acceptably labeled 1MT. NewLink may elect to produce bulk 1MT and formulated 1MT through contractors other than established [*] contractors in order to obtain the most competitive pricing. NewLink will then be responsible for subsequent payment of such contractors, and [*] will have no obligations with respect to such contractors. If NewLink elects to perform any portion of this CRADA Research Plan through a contractor or consultant, NewLink shall incorporate into such contracts all provisions necessary to ensure that the work of the contractor or consultant is governed by the terms of the CRADA, including, but not limited to, a provision for the assignment of inventions of the contractor or consultant to NewLink; such inventions shall be deemed [*] of NewLink. In addition, NewLink will ensure that any contractor or consultant is obligated to maintain [*] Confidential Information regarding 1MT manufacturing and formulation in confidence at least to the extent provided for by the terms of the CRADA. Following the use of [*] supplies of 1MT, NewLink will provide 1MT to [*] for use by [*] in [*] studies, studies designed to [*] of 1MT, and other studies relevant to the development of 1MT as provided in the Research Plan.
3. NewLink will prepare and submit to the FDA an Investigational New Drug Application (IND) for NewLink sponsored clinical studies of 1MT, which will cross-reference the DCTD IND.
4. XxxXxxx agrees to permit DCTD to supply formulated 1MT for all clinical trials set forth in this CRADA. This includes: · Provision of appropriately packaged and labeled 1MT for all NCI-sponsored clinical studies; · Supply of 1MT for compassionate use, as described in the NCI – Tracon CRADA (NCI# 02663)Investigator Handbook; and · Supply of 1MT for, Appendix A and any resources necessary for the management of, Group C distribution, as described in the NCI Investigator Handbook. Group C distribution shall be initiated if such action is justified by clinical results and is feasible based on adequate 1MT supply, such that NewLink’s NDA efforts are not negatively impacted. NewLink agrees to supply 1MT, or to provide unformulated analytical grade 1MT or metabolites, if available, to DCTD for DCTD to provide to DCTD intramural and extramural investigators for the development of analytical assays or ancillary correlative studies conducted in conjunction with DCTD-approved protocols. NewLink also agrees to provide 1MT for distribution for pre-clinical studies designed to enhance the basic understanding and development of 1MT. These will include pre-clinical studies designed to support clinical trials in […*]; pre-clinical [**…] Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A […***…]studies to provide data in support of a clinical trial; and other pertinent requests.
5. Investigational Drug Steering Committee (IDSC) The NCI Clinical Trials Working Group has mandated Upon CRADA execution, NewLink will provide resources for data collection and management, beyond that normally carried out by the formation DCTD as set forth in the CRADA for CTEP-sponsored studies, if NewLink desires such data collection and management. This would include the collection of the Investigational Drug Steering Committee (IDSC)data required to submit an NDA to the FDA.
6. The IDSC is designed Upon CRADA execution, NewLink may provide funds for partial support of the DCTD-sponsored clinical trials and IND.
7. Upon CRADA execution, NewLink will provide funds for travel by DCTD staff to provide DCTD attend meetings sponsored by NewLink concerning 1MT clinical trials, such funds not to exceed [*] per year of the term of the CRADA.
8. NewLink intends and will use reasonable efforts to prepare and submit an NDA to the FDA expeditiously when justified by clinical studies, with broad external scientific and clinical input the object of obtaining pharmaceutical regulatory approval for the design commercial marketing of 1MT.
9. NewLink may sponsor its own clinical trials using 1MT. Such Collaborator-sponsored trials are outside the scope of this CRADA. For these clinical trials, NewLink will maintain possession and prioritization of phase 1 and phase 2 trials with agents for which CTEP sponsors an IND. Membership control of the IDSC includes clinical trial results. NewLink will permit DCTD to review and use the principal investigators of phase 1 U01 grants and phase 2 N01 contracts, representatives from the NCI Cooperative Groups, NCI staff members, and additional representatives with expertise in biostatistics, correlative science technologies, radiation oncology, etc., as well as patient advocates and community oncologists, as needed. Experts with specific expertise will be included as ad hoc members results for consideration of specific agents. Periodically, the IDSC will assess, from a strategic perspective, CTEP investigational agent development plans, agent portfolios, and XXXx submitted by investigators to determine whether the DCTD-sponsored clinical development plan for an agent should be modified. When requested by CTEP, the IDSC will provide input on XXXx to assist in CTEP decision-making. All participating members will be vetted for conflict of interest and trials which are under confidentiality agreements with DCTDthe CRADA.
10. The IDS C is described in greater detail NewLink will update DCTD on p. 23 the progress of the report its preclinical studies of the Cancer Trials Working Group of National Cancer Advisory Board (xxxx://xxxxxxxxxxxxxxxx.xxx.xxx.xxx/ict/CTWG_report_June2005.pdf) Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A1MT to help ensure optimal experimental designs and avoid duplication.
Appears in 1 contract
Samples: Cooperative Research and Development Agreement (Newlink Genetics Corp)
RESPECTIVE CONTRIBUTIONS OF THE PARTIES. A. Joint Responsibilities
1. Steering Committee and Communication Plan A Steering Committee will may be employed by the Parties to exchange information and data and to discuss and to plan the proposed and ongoing clinical research. The Steering Committee shall be composed of the CRADA Principal Investigators from both Parties. In additionaddition , other NCI and Collaborator staff with expertise in toxicology, pharmacology, pharmaceutical development, project management and other disciplines, disciplines as pertinent to the current development stage of the Investigational Agent at the time of the meeting, meeting will be participating members. Both Parties shall report regularly to the Steering Committee on the progress of the clinical research and development efforts covered by this CRADA, will review the current progress, and will make any required decisions. The routes of communication, format of written minutes, etc. will be determined at the Steering Committee meetings and will be driven by the needs of the project. The Steering Committee will function under the oversight of Co-Chairs, one from NCI and one from the Collaborator. NCI’s Steering Committee Co-Chair will be appointed by the DCTD Division Director and report to the DCTD Division Director or his or her designee. Steering Committee meeting minutes summarizing all key decisions and issues under discussion will be provided to all the Steering Committee members and to the DCTD Division Director within ten (10) days [*] of each meeting. All Steering Committee decisions will be made by consensus[*]. In addition to the Steering Committee, Committee a Project Team comprised of project team comprising NCI and Collaborator scientific members will be assembled for the purpose of discussing the DCTD Clinical Support AssaysAssays may be assembled. This Project Team project team will be a collaborative body to approve projects described in Section 5C1 of this Appendix A which outlines the DCTD Clinical Support Assays. This Project Team project team will be a collaborative body charged with the planning and successful execution of experimental objectives. It is intended that study areas approved by the Project Team project team will be broad enough in scope to allow all necessary experiments to realize the goal of said research without further approval from the Project Teamproject team. Submission of new projects/areas of inquiry will be addressed by the Project Teams project team within seven (7) days [*] of receipt. Disagreements between DCTD and Collaborator will be discussed by the Steering Committee and/or Project Team project team who may recommend a course of action. In the event that Project Team project team is unable to reach consensus, it will be the Division Director’s responsibility [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. to resolve any Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A impasse. The Division Director will confer with representatives of the Collaborator before making any decision. Project Teams teams will meet quarterly, or more often if necessitated by results or submission of a new projectprojects/area of inquiry.
2. The DCTD and Collaborator will may explore the clinical utility of Investigational Agent for various cancers. As sensitive tumor types are identified, it will be important to develop combinations of Investigational Agent and other active anti-cancer agents and to compare Investigational Agent and Investigational Agent combinations with standard therapy for these tumor types. Adjuvant studies may be important in diseases where Investigational Agent has activity and where there is a high risk of recurrence following initial primary therapy.
3. Both Parties shall collaborate in the collection and analysis of data generated under the Research Plan.
4. Both Parties will work closely together to ensure that the clinical studies move forward expeditiously.
5. The Parties acknowledge that [*] means any [*] that is either readily usable as a [*] or is [*] that will be useful to [*] in developing [*] (rather than useful [*] or [*]). A [*] may simultaneously be a [*] and be the essence of a [*], or [*] (or an integral component of such [*]). For the purposes of this CRADA, [*] shall include, but not be limited to, [*]. If NewLink elects to request a [*] that is a [*], such [*] will ensure, as appropriate for the circumstances, that (a) the [*] will undertake to make the [*] on a [*] to [*] for [*] under [*], such [*], or (b) [*] the right to make the [*] on a [*] to [*] for [*] purposes under [[*].
B. Collaborator Responsibilities
C. DCTD Responsibilities
1. Collaborator, […*], will supply formulated Investigational Agent for the ongoing clinical trials identified in Section 3 of this Apendix A and supportive Non-Clinical Studies as provided under the CRADA. Collaborator may elect to produce bulk 1MT and formulated 1MT through contractors other than established [*] contractors in order to obtain the most competitive pricing. Collaborator will then be responsible for subsequent payment of such contractors, and [*…] will have no obligations with respect to such contractors. If Collaborator elects to perform any portion of this CRADA Research Plan through a contractor or consultant, Collaborator shall incorporate into such contracts all provisions necessary to ensure that the work of the contractor or consultant is governed by the terms of the CRADA, including, but not limited to, a provision for the assignment of inventions of the contractor or consultant to Collaborator; such inventions shall be deemed [*] of Collaborator. In addition, Collaborator will ensure that any contractor or consultant is obligated to maintain [*] Confidential NCI – Tracon CRADA (NCI# 02663)Information regarding 1MT manufacturing and [ * ] = Certain confidential information contained in this document, Appendix A […***…] Confidential NCI – Tracon CRADA (NCI# 02663)marked by brackets, Appendix A […***…]
5. Investigational Drug Steering Committee (IDSC) The NCI Clinical Trials Working Group has mandated is filed with the formation Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. formulation in confidence at least to the extent provided for by the terms of the CRADA. Collaborator’s supply of Investigation Agent includes and unless otherwise agreed between the Parties shall be limited to the following : • Provision of appropriately packaged and labeled Investigational Drug Steering Agent for NCI-sponsored clinical studies initiated under this CRADA. • Supply of Investigational Agent, or unformulated analytical grade Investigational Agent or metabolites, if available, to DCTD for DCTD to provide to NCI Intramural Investigators and NCI Extramural Investigators for the development of analytical assays or ancillary correlative studies conducted in conjunction with clinical Protocol Letters of Intent (XXXx) that are approved by the DCTD’s Protocol Review Committee (IDSC)and Collaborator under this CRADA. The IDSC is • Supply of Investigational Agent for distribution to NCI Intramural Investigators and NCI Extramural Investigators for Non-Clinical Studies designed to enhance the basic understanding and development of Investigational Agent as provided for in Section 3.8.4. These will include non-clinical studies designed to support clinical trials in [*]; non-clinical [*] studies to provide data in support of a clinical trial; and other pertinent requests. • Provision of Investigational Agent for DCTD Clinical Support Assays as described in Section 5(C)1 of this Appendix A.
2. Collaborator will provide resources for data collection and management, beyond that normally carried out by the DCTD as set forth in the CRADA for CTEP-sponsored studies, if Collaborator desires such data collection and management. This would include the collection of the data required to submit an NDA to the FDA.
3. Collaborator intends and will use reasonable efforts to prepare and submit an NDA to the FDA expeditiously when justified by clinical studies, with broad external scientific and clinical input the object of obtaining pharmaceutical regulatory approval for the design commercial marketing of Investigational Agent.
4. Collaborator may sponsor its own clinical trials and prioritization carry out its own non-clinical studies using Investigational Agent, Such Collaborator-sponsored trials and studies are outside the scope of phase 1 this CRADA. For these clinical trials and phase 2 trials with agents for which CTEP sponsors an IND. Membership studies, Collaborator will maintain possession and control of the IDSC includes clinical trial and study results. Collaborator will permit DCTD to review and use the principal investigators results for DCTD- [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of phase 1 U01 grants and phase 2 N01 contracts, representatives from the NCI Cooperative Groups, NCI staff members, and additional representatives with expertise in biostatistics, correlative science technologies, radiation oncology, etc.Securities Exchange Act of 1934, as well as patient advocates and community oncologists, as neededamended. Experts with specific expertise will be included as ad hoc members for consideration of specific agents. Periodically, the IDSC will assess, from a strategic perspective, CTEP investigational agent development plans, agent portfolios, and XXXx submitted by investigators to determine whether the sponsored clinical development plan for an agent should be modified. When requested by CTEP, the IDSC will provide input on XXXx to assist in CTEP decision-making. All participating members will be vetted for conflict of interest and trials which are under confidentiality agreements with DCTD. The IDS C is described in greater detail on p. 23 of the report of the Cancer Trials Working Group of National Cancer Advisory Board (xxxx://xxxxxxxxxxxxxxxx.xxx.xxx.xxx/ict/CTWG_report_June2005.pdf) Confidential NCI – Tracon CRADA (NCI# 02663), Appendix ACRADA.
Appears in 1 contract
Samples: Cooperative Research and Development Agreement (Newlink Genetics Corp)
RESPECTIVE CONTRIBUTIONS OF THE PARTIES. A. Joint Responsibilities
1. Steering Committee and Communication Plan A Steering Committee will be employed by the Parties to exchange information and data and to discuss and to plan the proposed and ongoing clinical research. The Steering Committee shall be composed of the CRADA Principal Investigators from both PartiesNCI and NewLink. In addition, other NCI and Collaborator NewLink staff with expertise in toxicology, pharmacology, pharmaceutical development, project management and other disciplines, disciplines as pertinent to the current development stage of the Investigational Agent at the time of a meeting may participate in the meeting, will be participating membersmeetings of the Steering Committee. Both Parties shall report regularly to the Steering Committee on the progress of the clinical research and development efforts covered by this CRADA, will review the current progress, and will make any required decisions. The routes of communication, format of written minutes, etc. will be determined at the Steering Committee meetings and will be driven by the needs of the project. The Parties have been meeting regularly prior to the execution of this CRADA Letter of Intent, and will continue to do so. [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The Steering Committee will function under the oversight of Co-Chairs, one from NCI and one from the Collaborator. NCI’s Steering Committee Co-Chair will be appointed by the DCTD Division Director and report to the DCTD Division Director or his or her designee. Steering Committee meeting minutes summarizing all key decisions and issues under discussion will be provided to all the Steering Committee members and to the DCTD Division Director within ten (10) days [*] of each meeting. Steering Committee decisions will be made by consensus. In addition to the Steering Committee, a Project Team comprised of NCI and Collaborator scientific members will be assembled for the purpose of discussing the DCTD Clinical Support Assays. This Project Team will be a collaborative body to approve projects described in Section 5C1 of this Appendix A which outlines the DCTD Clinical Support Assays. This Project Team will be a collaborative body charged with the planning and successful execution of experimental objectives. It is intended that study areas approved by the Project Team will be broad enough in scope to allow all necessary experiments to realize the goal of said research without further approval from the Project Team. Submission of new projects/areas of inquiry will be addressed by the Project Teams within seven (7) days of receipt. Disagreements between DCTD and Collaborator will be discussed by the Steering Committee and/or Project Team who may recommend a course of action. In the event that Project Team is unable to reach consensus, it will be the Division Director’s responsibility to resolve any Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A impasse. The Division Director will confer with representatives of the Collaborator before making any decision. Project Teams will meet quarterly, or more often if necessitated by results or submission of a new project/area of inquiry[*].
2. DCTD’s preclinical and ancillary studies shall be conducted [*], as per [*].
3. The DCTD and Collaborator NewLink will explore the clinical utility of Investigational Agent 1MT for various cancers. As sensitive tumor types are identified, it will be important to develop combinations of Investigational Agent 1MT and other active anti-cancer agents and to compare Investigational Agent 1MT and Investigational Agent 1MT combinations with standard therapy for these tumor types. Adjuvant studies may be important in diseases where Investigational Agent 1MT has activity and where there is a high risk of recurrence following initial primary therapy.
34. Both Parties shall collaborate in the collection and analysis of data generated under the Research Plan.
45. Both Parties will work closely together to ensure that the pre-clinical and clinical studies move forward expeditiously.
6. Subject to the obligations of the Parties to maintain the data under this CRADA as confidential and proprietary, the Parties may publicly disclose the results of their research under the circumstances set forth in the model CRADA.
7. When pre-clinical studies and/or a CRADA clinical protocol involves either [*] or involves [*], the NCI, NewLink [*] will jointly determine a reasonable and appropriate mechanism for intellectual property and data access and sharing prior to initiation of the pre-clinical studies and/or the clinical trial.
8. For activities conducted pursuant to this CRADA in the United States of America, both Parties agree to comply with all appropriate DHHS regulations relating to Human Subjects Use, all U.S. Department of Agriculture regulations, and all Public Health Service policies relating to the use and care of laboratory animals. For activities conducted pursuant to this CRADA outside of the United States of America, both Parties shall conduct such in accordance with GLPs and all applicable rules, regulations and statutes, both local and national, governing such activity in that country.
9. The Parties acknowledge that [*] means any [*] that is either readily usable as a [*] or is [*] that will be useful to [*] in developing [*] (rather than useful [*] or [*]). A [*] may simultaneously be a [*] and be the essence of a [*], or [*] (or an integral component of such [*]). For the purposes of this CRADA, [*] shall include, but not be limited to, a [*]. If NewLink elects to request [*] that is a [*], such [*] will ensure, as appropriate for [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. the circumstances, that (a) the [*] will undertake to make the [*] on a [*] to [*] for [*] under [*], such [*], or (b) [*] the right to make the [*] on a [*] to [*] for [*] purposes under [*].
B. Collaborator Responsibilities
C. DCTD NewLink Responsibilities
1. Following execution of the CRADA, NewLink will provide […*] funding for pre-clinical studies including the IND-directed toxicity studies and formulation studies which will be conducted by [*]. The exact amount of funding and the payment schedule will be agreed upon and addressed in an Appendix B to the executed CRADA.
2. Following CRADA execution, NewLink will be responsible for the [*…] cost of GMP-grade 1MT in current [*] inventories manufactured to support pre-clinical studies, NCI-sponsored [*] clinical trials, and NewLink-sponsored [*] clinical trials. The exact amount of funding and the payment schedule will be agreed upon and addressed in an Appendix B to the executed CRADA. If additional formulated 1MT is required for clinical studies under this CRADA Research Plan, NewLink will be responsible for the provision and costs of such extra supply of formulated and acceptably labeled 1MT. NewLink may elect to produce bulk 1MT and formulated 1MT through contractors other than established [*] contractors in order to obtain the most competitive pricing. NewLink will then be responsible for subsequent payment of such contractors, and [*] will have no obligations with respect to such contractors. If NewLink elects to perform any portion of this CRADA Research Plan through a contractor or consultant, NewLink shall incorporate into such contracts all provisions necessary to ensure that the work of the contractor or consultant is governed by the terms of the CRADA, including, but not limited to, a provision for the assignment of inventions of the contractor or consultant to NewLink; such inventions shall be deemed [*] of NewLink. In addition, NewLink will ensure that any contractor or consultant is obligated to maintain [*] Confidential Information regarding 1MT manufacturing and formulation in confidence at least to the extent provided for by the terms of the CRADA. Following the use of [*] supplies of 1MT, NewLink will provide 1MT to [*] for use by [*] in [*] studies, studies designed to [*] of 1MT, and other studies relevant to the development of 1MT as provided in the Research Plan.
3. NewLink will prepare and submit to the FDA an Investigational New Drug Application (IND) for NewLink sponsored clinical studies of 1MT, which will cross-reference the DCTD IND.
4. NewLink agrees to permit DCTD to supply formulated 1MT for all clinical trials set forth in this CRADA. This includes: • Provision of appropriately packaged and labeled 1MT for all NCI-sponsored clinical [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. studies; • Supply of 1MT for compassionate use, as described in the NCI – Tracon CRADA (NCI# 02663)Investigator Handbook; and • Supply of 1MT for, Appendix A and any resources necessary for the management of, Group C distribution, as described in the NCI Investigator Handbook. Group C distribution shall be initiated if such action is justified by clinical results and is feasible based on adequate 1MT supply, such that NewLink’s NDA efforts are not negatively impacted. NewLink agrees to supply 1MT, or to provide unformulated analytical grade 1MT or metabolites, if available, to DCTD for DCTD to provide to DCTD intramural and extramural investigators for the development of analytical assays or ancillary correlative studies conducted in conjunction with DCTD-approved protocols. NewLink also agrees to provide 1MT for distribution for pre-clinical studies designed to enhance the basic understanding and development of 1MT. These will include pre-clinical studies designed to support clinical trials in […*]; pre-clinical [**…] Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A […***…]studies to provide data in support of a clinical trial; and other pertinent requests.
5. Investigational Drug Steering Committee (IDSC) The NCI Clinical Trials Working Group has mandated Upon CRADA execution, NewLink will provide resources for data collection and management, beyond that normally carried out by the formation DCTD as set forth in the CRADA for CTEP-sponsored studies, if NewLink desires such data collection and management. This would include the collection of the Investigational Drug Steering Committee (IDSC)data required to submit an NDA to the FDA.
6. The IDSC is designed to Upon CRADA execution, NewLink may provide DCTD with broad external scientific and clinical input funds for the design and prioritization of phase 1 and phase 2 trials with agents for which CTEP sponsors an IND. Membership partial support of the IDSC includes the principal investigators of phase 1 U01 grants DCTD-sponsored clinical trials and phase 2 N01 contracts, representatives from the NCI Cooperative Groups, NCI staff members, and additional representatives with expertise in biostatistics, correlative science technologies, radiation oncology, etcIND., as well as patient advocates and community oncologists, as needed. Experts with specific expertise will be included as ad hoc members for consideration of specific agents. Periodically, the IDSC will assess, from a strategic perspective, CTEP investigational agent development plans, agent portfolios, and XXXx submitted by investigators to determine whether the clinical development plan for an agent should be modified. When requested by CTEP, the IDSC will provide input on XXXx to assist in CTEP decision-making. All participating members will be vetted for conflict of interest and are under confidentiality agreements with DCTD. The IDS C is described in greater detail on p. 23 of the report of the Cancer Trials Working Group of National Cancer Advisory Board (xxxx://xxxxxxxxxxxxxxxx.xxx.xxx.xxx/ict/CTWG_report_June2005.pdf) Confidential NCI – Tracon CRADA (NCI# 02663), Appendix A
Appears in 1 contract
Samples: Cooperative Research and Development Agreement (Newlink Genetics Corp)
