Common use of Inventions, Discoveries and Patents Clause in Contracts

Inventions, Discoveries and Patents. 8.1. It is recognized and understood that certain existing inventions and technologies, and those arising outside of the research conducted under this Agreement, are the separate property of Sponsor or Institution and are not affected by this Agreement, and neither Party shall have any claims to or rights in such separate inventions and technologies. 8.2. Any new patentable inventions, developments, or discoveries made during and in the performance of the Study (“Inventions”) shall be promptly disclosed to Sponsor. Title to Inventions that necessarily use or necessarily incorporate Sponsor’s Study Drug and/or Study Device shall reside with Sponsor (“Sponsor Inventions”). Institution shall assign all Sponsor Inventions to Sponsor in writing. Title to Inventions other than Sponsor Inventions (“Other Inventions”) shall reside with Sponsor if Sponsor personnel are the sole inventors, with Institution if Institution personnel are the sole inventors, and shall be held jointly if both Institution and Sponsor personnel are inventors. 8.3. To the extent that Institution owns sole or joint title in any such Other Inventions, Sponsor is hereby granted, without option fee other than consideration of the Study sponsored herein and the reimbursement to Institution for patent expenses incurred prior to or during the option period, an option to acquire an exclusive, worldwide, royalty-bearing license to Institution's rights to any Other Invention, which option shall extend for no more than ninety (90) days after Sponsor’s receipt of an Invention disclosure from Institution (“Option Period”). The Parties shall use their reasonable efforts to negotiate, for a period not to exceed ninety (90) days after Sponsor’s exercise of such option, a license agreement satisfactory to both Parties (“Negotiation Period”). In the event Sponsor fails to exercise its option within the Option Period, or the Parties fail to reach agreement on the terms of such license within the Negotiation Period, Institution shall have no further obligation to Sponsor under this Agreement with regard to the specific Other Invention. 8.4. Institution shall retain a royalty-free, irrevocable license to use for its own internal noncommercial research, educational and patient care purposes, all Sponsor Inventions or Other Inventions licensed or assigned to Sponsor hereunder. 8.5. Nothing contained in this Agreement shall be deemed to grant either directly by implication, estoppel, or otherwise any license under any patents, patent applications, or other proprietary interest to any other inventions, discovery or improvement of either Party. 8.6. The Parties agree that the provisions of this Agreement are intended to be interpreted and implemented so as to comply with all applicable federal laws, rules, and regulations, including without limitation the requirements of Rev. Proc. 2007-47; provided, however, if it is determined by the Internal Revenue Service or any other federal agency or instrumentality (the "Government") that the provisions of this Agreement are not in such compliance, then the Parties agree to modify the provisions and the implementation of this Agreement so as to be in compliance with all applicable federal laws, rules, and regulations as determined by the Government.

Inventions, Discoveries and Patents. 8.1. It is recognized and understood that certain existing inventions and technologies, and those arising outside of the research conducted under this Agreement, are the separate property of Sponsor or Institution and are not affected by this Agreement, and neither Party shall have any claims to or rights in such separate inventions and technologies. 8.2. Any new patentable inventions, developments, or discoveries discoveries, made during and in the performance of the Study Protocol (“Inventions”) shall be promptly disclosed to Sponsor. Title to Inventions that necessarily use which are enhancements, modifications or necessarily incorporate improvements, of the {CHOOSE: Sponsor’s Study Drug and/or Study Device Device} and that are made during and under this Agreement shall reside with Sponsor (“Sponsor Inventions”). Institution shall assign all Sponsor Inventions to Sponsor. Institution represents and certifies that all Institution personnel, including Principal Investigator, performing the Protocol have assigned to or are obligated to assign to Institution (or appropriate technology transfer office, on behalf of Institution), all their rights in or to Inventions that are necessary to enable Institution to grant Sponsor in writingall rights to Inventions that Institution purports to grant under this Agreement. Title to Inventions other than Sponsor Inventions (“Other Inventions”) shall reside with Sponsor if Sponsor personnel are the sole inventors, with Institution if Institution personnel are the sole inventors, and shall be held jointly if both Institution and Sponsor personnel are inventors. Institution’s obligations under Sections 8.2 and 8.3 hereunder shall be performed by its appropriate office with technology transfer responsibilities, if required by and in accordance with Institution policies. 8.3. To the extent that Institution owns sole or joint title in any such Other Inventions, Sponsor is hereby granted, without option fee other than consideration of the Study sponsored herein and the reimbursement to Institution for patent expenses incurred prior to or during the option period, an option to acquire an exclusive, worldwide, royalty-bearing license to Institution's ’s rights to any Other Invention, which option shall extend for no more than ninety (90) days after Sponsor’s receipt of an Invention disclosure from Institution (“Option Period”). The Parties shall use their reasonable efforts to negotiate, for a period not to exceed ninety (90) days after Sponsor’s exercise of such option, a license agreement satisfactory to both Parties (“Negotiation Period”). In the event Sponsor fails to exercise its option within the Option Period, or the Parties fail to reach agreement on the terms of such license within the Negotiation Period, Institution shall have no further obligation to Sponsor under this Agreement with regard to the specific Other Invention. 8.4. Institution shall retain have a royalty-free, irrevocable license right to use for its own internal noncommercial research, educational and patient care purposes, all Sponsor Inventions or Other Inventions licensed or assigned to Sponsor hereunder. 8.5. Nothing contained in this Agreement shall be deemed to grant either directly by implication, estoppel, or otherwise any license under any patents, patent applications, or other proprietary interest to any other inventions, discovery or improvement of either Party. 8.6. The Parties agree that the provisions of this Agreement are intended to be interpreted and implemented so as to comply with all applicable federal laws, rules, and regulations, including without limitation the requirements of Rev. Proc. 2007-47; provided, however, if it is determined by the Internal Revenue Service or any other federal agency or instrumentality (the "Government") that the provisions of this Agreement are not in such compliance, then the Parties agree to modify the provisions and the implementation of this Agreement so as to be in compliance with all applicable federal laws, rules, and regulations as determined by the Government.

Inventions, Discoveries and Patents. 8.1. It is recognized and understood that certain existing inventions and technologies, and those arising outside of the research conducted under this Agreement, are the separate property of Sponsor or Institution and are not affected by this Agreement, and neither Party shall have any claims to or rights in such separate inventions and technologies. 8.2. Any new patentable inventions, developments, or discoveries made during and in the performance of the Study (“Inventions”) shall be promptly disclosed to Sponsor. Title to Inventions that necessarily use or necessarily incorporate Sponsor’s Study Drug and/or Study Device shall reside with Sponsor (“Sponsor Inventions”). Institution shall assign all Sponsor Inventions to Sponsor in writing. Title to Inventions other than Sponsor Inventions (“Other Inventions”) shall reside with Sponsor if Sponsor personnel are the sole inventors, with Institution if Institution personnel are the sole inventors, and shall be held jointly if both Institution and Sponsor personnel are inventors. Institution’s obligations under Sections 8.2 and 8.3 hereunder shall be performed by its appropriate office with technology transfer responsibilities, if required by and in accordance with Institution policies. 8.3. To the extent that Institution owns sole or joint title in any such Other Inventions, Sponsor is hereby granted, without option fee other than consideration of the Study sponsored herein and the reimbursement to Institution for patent expenses incurred prior to or during the option period, an option to acquire an exclusive, worldwide, royalty-bearing license to Institution's ’s rights to any Other Invention, which option shall extend for no more than ninety (90) days after Sponsor’s receipt of an Invention disclosure from Institution (“Option Period”). The Parties shall use their reasonable efforts to negotiate, for a period not to exceed ninety (90) days after Sponsor’s exercise of such option, a license agreement satisfactory to both Parties (“Negotiation Period”). In the event Sponsor fails to exercise its option within the Option Period, or the Parties fail to reach agreement on the terms of such license within the Negotiation Period, Institution shall have no further obligation to Sponsor under this Agreement with regard to the specific Other Invention. 8.4. Institution shall retain a royalty-free, irrevocable license to use for its own internal noncommercial research, educational and patient care purposes, all Sponsor Inventions or Other Inventions licensed or assigned to Sponsor hereunder. 8.5. Nothing contained in this Agreement shall be deemed to grant either directly by implication, estoppel, or otherwise any license under any patents, patent applications, or other proprietary interest to any other inventions, discovery or improvement of either Party. 8.6. The Parties agree that the provisions of this Agreement are intended to be interpreted and implemented so as to comply with all applicable federal laws, rules, and regulations, including without limitation the requirements of Rev. Proc. 2007-47; provided, however, if it is determined by the Internal Revenue Service or any other federal agency or instrumentality (the "Government") that the provisions of this Agreement are not in such compliance, then the Parties agree to modify the provisions and the implementation of this Agreement so as to be in compliance with all applicable federal laws, rules, and regulations as determined by the Government.

Inventions, Discoveries and Patents. 8.1. It is recognized and understood that certain existing inventions and technologies, and those arising outside of the research conducted under this Agreement, are the separate property of Sponsor or Institution and are not affected by this Agreement, and neither Party Sponsor nor Institution shall have any claims to or rights in such separate inventions and technologies. 8.2. Any new patentable inventions, developments, or discoveries made during and in the performance of the Study (“Inventions”) shall be promptly disclosed to Sponsor. Title to Inventions that necessarily use or necessarily incorporate Sponsor’s Study Drug and/or Study Device shall reside with Sponsor (“Sponsor Inventions”). Institution shall assign all Sponsor Inventions to Sponsor in writing. Title to Inventions other than Sponsor Inventions (“Other Inventions”) shall reside with Sponsor if Sponsor personnel are the sole inventors, with Institution if Institution personnel are the sole inventors, and shall be held jointly if both Institution and Sponsor personnel are inventors. Institution’s obligations under Sections 8.2 and 8.3 hereunder shall be performed by its appropriate office with technology transfer responsibilities, if required by and in accordance with Institution policies. 8.3. To the extent that Institution owns sole or joint title in any such Other Inventions, Sponsor is hereby granted, without option fee other than consideration of the Study sponsored herein and the reimbursement to Institution for patent expenses incurred prior to or during the option period, an option to acquire an exclusive, worldwide, royalty-bearing license to Institution's rights to any Other Invention, which option shall extend for no more than ninety (90) days after Sponsor’s receipt of an Invention disclosure from Institution (“Option Period”). The Parties Sponsor and Institution shall use their reasonable efforts to negotiate, for a period not to exceed ninety (90) days after Sponsor’s exercise of such option, a license agreement satisfactory to both Parties parties (“Negotiation Period”). In the event Sponsor fails to exercise its option within the Option Period, or the Parties Sponsor and Institution fail to reach agreement on the terms of such license within the Negotiation Period, Institution shall have no further obligation to Sponsor under this Agreement with regard to the specific Other Invention. 8.4. Institution shall retain a royalty-free, irrevocable license to use for its own internal noncommercial research, educational and patient care purposes, all Sponsor Inventions or Other Inventions licensed or assigned to Sponsor hereunder. 8.5. Nothing contained in this Agreement shall be deemed to grant either directly by implication, estoppel, or otherwise any license under any patents, patent applications, or other proprietary interest to any other inventions, discovery or improvement of either PartySponsor or Institution. 8.6. The Parties CRO and Institution agree that the provisions of this Agreement are intended to be interpreted and implemented so as to comply with all applicable federal laws, rules, and regulations, including without limitation the requirements of Rev. Proc. 2007-47; provided, however, if it is determined by the Internal Revenue Service or any other federal agency or instrumentality (the "Government") that the provisions of this Agreement are not in such compliance, then the Parties those parties agree to modify the provisions and the implementation of this Agreement so as to be in compliance with all applicable federal laws, rules, and regulations as determined by the Government.

Inventions, Discoveries and Patents. 8.1. It is recognized and understood that certain existing inventions and technologies, and those arising outside of the research conducted under this Agreement, are the separate property of Sponsor or Institution and are not affected by this Agreement, and neither Party Sponsor nor Institution shall have any claims to or rights in such separate inventions and technologies. 8.2. Any new patentable inventions, developments, or discoveries made during and in the performance of the Study (“Inventions”) shall be promptly disclosed to Sponsor. Title to Inventions that necessarily use or necessarily incorporate Sponsor’s Study Drug and/or Study Device shall reside with Sponsor (“Sponsor Inventions”). Institution shall assign all Sponsor Inventions to Sponsor in writing. Title to Inventions other than Sponsor Inventions (“Other Inventions”) shall reside with Sponsor if Sponsor personnel are the sole inventors, with Institution if Institution personnel are the sole inventors, and shall be held jointly if both Institution and Sponsor personnel are inventors. Institution’s obligations under Sections 8.2 and 8.3 hereunder shall be performed by its appropriate office with technology transfer responsibilities, if required by and in accordance with Institution’s policies. 8.3. To the extent that Institution owns sole or joint title in any such Other Inventions, Sponsor is hereby granted, without option fee other than consideration of the Study sponsored herein and the reimbursement to Institution for patent expenses incurred prior to or during the option period, an option to acquire an exclusive, worldwide, royalty-bearing license to Institution's ’s rights to any Other Invention, which option shall extend for no more than ninety (90) days after Sponsor’s receipt of an Invention disclosure from Institution (“Option Period”). The Parties Sponsor and Institution shall use their reasonable efforts to negotiate, for a period not to exceed ninety (90) days after Sponsor’s exercise of such option, a license agreement satisfactory to both Parties parties (“Negotiation Period”). In the event Sponsor fails to exercise its option within the Option Period, or the Parties Sponsor and Institution fail to reach agreement on the terms of such license within the Negotiation Period, Institution shall have no further obligation to Sponsor under this Agreement with regard to the specific Other Invention. 8.4. Institution shall retain a royalty-free, irrevocable license to use for its own internal noncommercial research, educational and patient care purposes, all Sponsor Inventions or Other Inventions licensed or assigned to Sponsor hereunder. 8.5. Nothing contained in this Agreement shall be deemed to grant either directly by implication, estoppel, or otherwise any license under any patents, patent applications, or other proprietary interest to any other inventions, discovery or improvement of either PartySponsor or Institution. 8.6. The Parties CRO and Institution agree that the provisions of this Agreement are intended to be interpreted and implemented so as to comply with all applicable federal laws, rules, and regulations, including without limitation the requirements of Rev. Proc. 2007-47; provided, however, if it is determined by the Internal Revenue Service or any other federal agency or instrumentality (the "“Government"”) that the provisions of this Agreement are not in such compliance, then the Parties those parties agree to modify the provisions and the implementation of this Agreement so as to be in compliance with all applicable federal laws, rules, and regulations as determined by the Government.

Inventions, Discoveries and Patents. 8.1. It is recognized and understood that certain existing inventions and technologies, and those arising outside of the research conducted under this Agreement, are the separate property of Sponsor Sponsor, Institution or Institution Principal Investigator and are not affected by this Agreement, and neither Party Sponsor nor Institution nor Principal Investigator shall have any claims to or rights in such separate inventions and technologies. 8.2. Any new patentable inventions, developments, or discoveries made during and in the performance of the Study (“Inventions”) shall be promptly disclosed to Sponsor. Title to Inventions that necessarily use or necessarily incorporate Sponsor’s Study Drug and/or Study Device shall reside with Sponsor (“Sponsor Inventions”). Institution and Principal Investigator shall assign all Sponsor Inventions to Sponsor in writing. Title to Inventions other than Sponsor Inventions (“Other Inventions”) shall reside with Sponsor if Sponsor personnel are the sole inventors, with Institution if Institution personnel are the sole inventors, with Principal Investigator if Principal Investigator is the sole inventor, and shall be held jointly if both Institution and/or Principal Investigator and Sponsor personnel are inventors. 8.3. To the extent that Institution or Principal Investigator owns sole or joint title in any such Other Inventions, Sponsor is hereby granted, without option fee other than consideration of the Study sponsored herein and the reimbursement to Institution or Principal Investigator for patent expenses incurred prior to or during the option period, an option to acquire an exclusive, worldwide, royalty-bearing license to Institution's ’s or Principal Investigator’s rights to any Other Invention, which option shall extend for no more than ninety (90) days after Sponsor’s receipt of an Invention disclosure from Institution or Principal Investigator (“Option Period”). The Parties Sponsor and Institution and/or Principal Investigator shall use their reasonable efforts to negotiate, for a period not to exceed ninety (90) days after Sponsor’s exercise of such option, a license agreement satisfactory to both Parties all parties (“Negotiation Period”). In the event Sponsor fails to exercise its option within the Option Period, or the Parties Sponsor and Institution and/or Principal Investigator fail to reach agreement on the terms of such license within the Negotiation Period, Institution and Principal Investigator shall have no further obligation to Sponsor under this Agreement with regard to the specific Other Invention. 8.4. Institution and Principal Investigator shall retain a royalty-free, irrevocable license to use for its its/his/her own internal noncommercial research, educational and patient care purposes, all Sponsor Inventions or Other Inventions licensed or assigned to Sponsor hereunder. 8.5. Nothing contained in this Agreement shall be deemed to grant either directly by implication, estoppel, or otherwise any license under any patents, patent applications, or other proprietary interest to any other inventions, discovery or improvement of either PartySponsor, Institution or Principal Investigator. 8.6. The Parties CRO, Institution and Principal Investigator agree that the provisions of this Agreement are intended to be interpreted and implemented so as to comply with all applicable federal laws, rules, and regulations, including without limitation the requirements of Rev. Proc. 2007-47; provided, however, if it is determined by the Internal Revenue Service or any other federal agency or instrumentality (the "“Government"”) that the provisions of this Agreement are not in such compliance, then the Parties those parties agree to modify the provisions and the implementation of this Agreement so as to be in compliance with all applicable federal laws, rules, and regulations as determined by the Government.

Inventions, Discoveries and Patents. 8.1. It is recognized and understood that certain existing inventions and technologies, and those arising outside of the research conducted under this Agreement, are the separate property of Sponsor or Institution and are not affected by this Agreement, and neither Party Sponsor nor Institution shall have any claims to or rights in such separate inventions and technologies. 8.2. Any new patentable inventions, developments, or discoveries made during and in the performance of the Study (“Inventions”) shall be promptly disclosed to Sponsor. Title to Inventions that necessarily use or necessarily incorporate Sponsor’s Study Drug and/or Study Device shall reside with Sponsor (“Sponsor Inventions”). Institution shall assign all Sponsor Inventions to Sponsor in writing. Title to Inventions other than Sponsor Inventions (“Other Inventions”) shall reside with Sponsor if Sponsor personnel are the sole inventors, with Institution if Institution personnel are the sole inventors, and shall be held jointly if both Institution and Sponsor personnel are inventors. Institution’s obligations under Sections 8.2 and 8.3 hereunder shall be performed by its appropriate office with technology transfer responsibilities, if required by and in accordance with Institution policies. 8.3. To the extent that Institution owns sole or joint title in any such Other Inventions, Sponsor is hereby granted, without option fee other than consideration of the Study sponsored herein and the reimbursement to Institution for patent expenses incurred prior to or during the option period, an option to acquire an exclusive, worldwide, royalty-bearing license to Institution's ’s rights to any Other Invention, which option shall extend for no more than ninety (90) days after Sponsor’s receipt of an Invention disclosure from Institution (“Option Period”). The Parties shall use their reasonable efforts to negotiate, for a period not to exceed ninety (90) days after Sponsor’s exercise of such option, a license agreement satisfactory to both Parties (“Negotiation Period”). In the event Sponsor fails to exercise its option within the Option Period, or the Parties fail to reach agreement on the terms of such license within the Negotiation Period, Institution shall have no further obligation to Sponsor under this Agreement with regard to the specific Other Invention. 8.4. Institution shall retain a royalty-free, irrevocable license to use for its own internal noncommercial research, educational and patient care purposes, all Sponsor Inventions or Other Inventions licensed or assigned to Sponsor hereunder. 8.5. Nothing contained in this Agreement shall be deemed to grant either directly by implication, estoppel, or otherwise any license under any patents, patent applications, or other proprietary interest to any other inventions, discovery or improvement of either Party. 8.6. The Parties agree that the provisions of this Agreement are intended to be interpreted and implemented so as to comply with all applicable federal laws, rules, and regulations, including without limitation the requirements of Rev. Proc. 2007-47; provided, however, if it is determined by the Internal Revenue Service or any other federal agency or instrumentality (the "Government") that the provisions of this Agreement are not in such compliance, then the Parties agree to modify the provisions and the implementation of this Agreement so as to be in compliance with all applicable federal laws, rules, and regulations as determined by the Government.

Inventions, Discoveries and Patents. 8.1. It is recognized and understood that certain existing inventions and technologies, and those arising outside of the research conducted under this Agreement, are the separate property of Sponsor or Institution and are not affected by this Agreement, and neither Party shall have any claims to or rights in such separate inventions and technologies. 8.2. Any new patentable inventions, developments, or discoveries made during and in the performance of the Study Protocol (“Inventions”) shall be promptly disclosed to Sponsor. Title to Inventions that necessarily use which are enhancements, modifications or necessarily incorporate improvements, of the {CHOOSE: Sponsor’s Study Drug and/or Study Device Device} and that are made during and under this Agreement shall reside with the Sponsor (“Sponsor Inventions”). Institution shall assign all Sponsor Inventions to Sponsor. Institution represents and certifies that all Institution personnel, including Principal Investigator, performing the Protocol have assigned to or are obligated to assign to Institution (or appropriate technology transfer office, on behalf of Institution), all their rights in or to Inventions that are necessary to enable Institution to grant Sponsor in writingall rights to Inventions that Institution purports to grant under this Agreement. Title to Inventions other than Sponsor Inventions (“Other Inventions”) shall reside with Sponsor if Sponsor personnel are the sole inventors, with Institution if Institution personnel are the sole inventors, and shall be held jointly if both Institution and Sponsor personnel are inventors. Institution’s obligations under Sections 8.2 and 8.3 hereunder shall be performed by its appropriate office with technology transfer responsibilities, if required by and in accordance with Institution policies. 8.3. To the extent that Institution owns sole or joint title in any such Other Inventions, Sponsor is hereby granted, without option fee other than consideration of the Study sponsored herein and the reimbursement to Institution for patent expenses incurred prior to or during the option period, an option to acquire an exclusive, worldwide, royalty-bearing license to Institution's ’s rights to any Other Invention, which option shall extend for no more than ninety (90) days after Sponsor’s receipt of an Invention disclosure from Institution (“Option Period”). The Parties shall use their reasonable efforts to negotiate, for a period not to exceed ninety (90) days after Sponsor’s exercise of such option, a license agreement satisfactory to both Parties (“Negotiation Period”). In the event Sponsor fails to exercise its option within the Option Period, or the Parties fail to reach agreement on the terms of such license within the Negotiation Period, Institution shall have no further obligation to Sponsor under this Agreement with regard to the specific Other Invention. 8.4. Institution shall retain have a royalty-free, irrevocable license right to use for its own internal noncommercial research, educational and patient care purposes, all Sponsor Inventions or Other Inventions licensed or assigned to Sponsor hereunder. 8.5. Nothing contained in this Agreement shall be deemed to grant either directly by implication, estoppel, or otherwise any license under any patents, patent applications, or other proprietary interest to any other inventions, discovery or improvement of either Party. 8.6. The Parties agree that the provisions of this Agreement are intended to be interpreted and implemented so as to comply with all applicable federal laws, rules, and regulations, including without limitation the requirements of Rev. Proc. 2007-47; provided, however, if it is determined by the Internal Revenue Service or any other federal agency or instrumentality (the "Government") that the provisions of this Agreement are not in such compliance, then the Parties agree to modify the provisions and the implementation of this Agreement so as to be in compliance with all applicable federal laws, rules, and regulations as determined by the Government.

Inventions, Discoveries and Patents. 8.1. It is recognized and understood that certain existing inventions and technologies, and those arising outside of the research conducted under this Agreement, are the separate property of Sponsor Sponsor, Coordinating Center or Institution the Study Site and are not affected by this Agreement, and neither Party shall have any . No claims to or rights in such separate inventions and technologiestechnologies shall transfer by operation of this Agreement. 8.2. Any new patentable inventions, developments, or discoveries made during and in the performance of the Study (“Inventions”) shall be promptly disclosed to Sponsor. Title to Inventions that necessarily use or necessarily incorporate Sponsor’s Study Drug and/or Study Device shall reside with Sponsor (“Sponsor Inventions”). Institution Coordinating Center shall, and shall ensure the Study Sites agree to, assign all Sponsor Inventions to Sponsor in writing. Title to Inventions other than Sponsor Inventions (“Other Inventions”) shall reside with Sponsor if Sponsor personnel are the sole inventors, with Institution if Institution Coordinating Center and/or Study Site whose personnel are the sole inventors, and shall be held jointly if both Institution Coordinating Center and/or Study Site and Sponsor personnel are inventors. The Coordinating Center’s and Study Sites’ obligations under Sections 8.2 and 8.3 shall be performed by each institution’s appropriate office with technology transfer responsibilities, if required by and in accordance with its respective policies. 8.3. To the extent that Institution Coordinating Center and/or a Study Site owns sole or joint title in any such Other Inventions, Sponsor is hereby grantedCoordinating Center grants, and shall ensure Study Site agrees to grant, Sponsor, without option fee other than consideration of the Study sponsored herein and the reimbursement to Institution Coordinating Center and/or that Study Site for patent expenses incurred prior to or during the option period, an option to acquire an exclusive, worldwide, royalty-bearing license to Institutionthe applicable party's rights to any Other Invention, which option shall extend for no more than ninety (90) days after Sponsor’s receipt of an Invention disclosure from Institution Coordinating Center and/or the Study Site (“Option Period”). The Parties Sponsor and Coordinating Center shall, and Coordinating Center shall ensure the Study Sites agree to, use their reasonable efforts to negotiate, for a period not to exceed ninety (90) days after Sponsor’s exercise of such option, a license agreement satisfactory to both Parties Sponsor, Coordinating Center and/or Study Site (“Negotiation Period”). In the event Sponsor fails to exercise its option within the Option Period, or the Parties applicable Coordinating Center and/or Study Site fail to reach agreement on the terms of such license within the Negotiation Period, Institution Coordinating Center and/or the Study Site shall have no further obligation to Sponsor under this Agreement with regard to the specific Other Invention. 8.4. Institution Coordinating Center and Study Sites shall each retain a royalty-free, irrevocable license to use for its own internal noncommercial research, educational and patient care purposes, all Sponsor Inventions or Other Inventions licensed or assigned to Sponsor hereunder. 8.5. Nothing contained in this Agreement shall be deemed to grant either directly by implication, estoppel, or otherwise any license under any patents, patent applications, or other proprietary interest to any other inventions, discovery or improvement of either PartySponsor, Coordinating Center or Study Sites. 8.6. The Parties agree that the provisions of this Agreement are intended to be interpreted and implemented so as to comply with all applicable federal laws, rules, and regulations, including without limitation the requirements of Rev. Proc. 2007-47; provided, however, if it is determined by the Internal Revenue Service or any other federal agency or instrumentality (the "Government") that the provisions of this Agreement are not in such compliance, then the Parties agree to modify the provisions and the implementation of this Agreement so as to be in compliance with all applicable federal laws, rules, and regulations as determined by the Government.

Inventions, Discoveries and Patents. 8.1. It is recognized and understood that certain existing inventions and technologies, and those arising outside of the research conducted under this Agreement, are the separate property of Sponsor or Institution and are not affected by this Agreement, and neither Party Sponsor nor Institution shall have any claims to or rights in such separate inventions and technologies. 8.2. Any new patentable inventions, developments, or discoveries made during and in the performance of the Study (“Inventions”) shall be promptly disclosed to Sponsor. Title to Inventions that necessarily use or necessarily incorporate Sponsor’s Study Drug and/or Study Device shall reside with Sponsor (“Sponsor Inventions”). Institution shall assign all Sponsor Inventions to Sponsor in writing. Title to Inventions other than Sponsor Inventions (“Other Inventions”) shall reside with Sponsor if Sponsor personnel are the sole inventors, with Institution if Institution personnel are the sole inventors, and shall be held jointly if both Institution and Sponsor personnel are inventors. Institution’s obligations under Sections 8.2 and 8.3 hereunder shall be performed by its appropriate office with technology transfer responsibilities, if required by and in accordance with Institution’s policies. 8.3. To the extent that Institution owns sole or joint title in any such Other Inventions, Sponsor is hereby granted, without option fee other than consideration of the Study sponsored herein and the reimbursement to Institution for patent expenses incurred prior to or during the option period, an option to acquire an exclusive, worldwide, royalty-bearing license to Institution's ’s rights to any Other Invention, which option shall extend for no more than ninety (90) days after Sponsor’s receipt of an Invention disclosure from Institution (“Option Period”). The Parties Sponsor and Institution shall use their reasonable efforts to negotiate, for a period not to exceed ninety (90) days after Sponsor’s exercise of such option, a license agreement satisfactory to both Parties parties (“Negotiation Period”). In the event Sponsor fails to exercise its option within the Option Period, or the Parties Sponsor and Institution fail to reach agreement on the terms of such license within the Negotiation Period, Institution shall have no further obligation to Sponsor under this Agreement with regard to the specific Other Invention. 8.4. Institution shall retain a royalty-free, irrevocable license to use for its own internal noncommercial research, educational and patient care purposes, all Sponsor Inventions or Other Inventions licensed or assigned to Sponsor hereunderhere under. 8.5. Nothing contained in this Agreement shall be deemed to grant either directly by implication, estoppel, or otherwise any license under any patents, patent applications, or other proprietary interest to any other inventions, discovery or improvement of either PartySponsor or Institution. 8.6. The Parties CRO and Institution agree that the provisions of this Agreement are intended to be interpreted and implemented so as to comply with all applicable federal laws, rules, and regulations, including without limitation the requirements of Rev. Proc. 2007-47; provided, however, if it is determined by the Internal Revenue Service or any other federal agency or instrumentality (the "“Government"”) that the provisions of this Agreement are not in such compliance, then the Parties those parties agree to modify the provisions and the implementation of this Agreement so as to be in compliance with all applicable federal laws, rules, and regulations as determined by the Government.

Inventions, Discoveries and Patents. 8.1. 8.1 It is recognized and understood that certain existing inventions and technologiestechnologies owned or licensed by a Party as of the Effective Date, and those arising outside of the research conducted under this Agreement, are the separate property of Sponsor or Institution and are not affected by this Agreement, and neither Party shall have any claims to or rights in such separate inventions and technologies. 8.2. 8.2 Any new patentable inventions, developments, or discoveries made during and in the performance of the Study (“Inventions”) shall be promptly disclosed to Sponsor. Title to Inventions that necessarily use or necessarily incorporate Sponsor’s Study Drug and/or Study Device and which are contemplated by the Study shall reside with Sponsor (“Sponsor Inventions”). Institution shall assign all Sponsor Inventions to Sponsor in writing. Institution shall, as reasonably requested by Sponsor, render reasonable assistance to the Sponsor in the filing and prosecution of any United States and foreign counterpart part applications in regards to the Sponsor Inventions and otherwise perfecting Sponsor’s rights in the Sponsor Inventions. Sponsor shall provide reasonable compensation to the Institution for the time devoted to such activities and reimburse Institution for all reasonable expenses in regards to such activities. Title to Inventions other than Sponsor Inventions (“Other Inventions”) shall reside with Sponsor if Sponsor personnel are the sole inventors, with Institution if Institution personnel are the sole inventors, and shall be held jointly if both Institution and Sponsor personnel are inventors. Inventorship will be determined in accordance with the principles of United States patent law, regardless of whether the Invention is patentable. The Institution shall have the sole and exclusive right to obtain patent protection in the United States and foreign countries on any Other Inventions to which it owns sole or joint title. During the Option Period (as defined below), Sponsor may request and Institution shall, at Sponsor’s expense, file a patent application in regard to an Other Invention to which Institution owns sole or joint title. 8.3. 8.3 To the extent that Institution owns sole or joint title in any such Other Inventions, Sponsor is hereby granted, without option fee other than consideration of the Study sponsored herein and the reimbursement to Institution for patent expenses incurred prior to or during the option period, an option to acquire an exclusive, worldwide, royalty-bearing license to Institution's rights to any Other Invention, which option shall extend for no more than ninety (90) days after Sponsor’s receipt of an Invention disclosure from Institution (“Option Period”). The Parties shall use their reasonable efforts to negotiate, for a period not to exceed ninety (90) days after Sponsor’s exercise of such option, a license agreement satisfactory to both Parties (“Negotiation Period”). Any such license agreement will include reimbursement to Institution for costs of filing, prosecuting and maintaining any patent or other intellectual property application related to the Inventions. In the event Sponsor fails to exercise its option within the Option Period, or the Parties fail to reach agreement on the terms of such license within the Negotiation Period, Institution shall have no further obligation to Sponsor under this Agreement with regard to the specific Other Invention. 8.48.4 Sponsor shall keep Institution fully informed, on at least an annual basis, as to the commercial development of any Other Inventions to which Institution has joint title (the “Annual Joint Invention Report”). If the Other Invention to which Institution has joint title is licensed, sublicensed, assigned or otherwise transferred to a party by Sponsor or Sponsor receives any compensation, fees, royalties or other consideration in regards to the commercialization of such Other Invention, Institution shall retain a royalty-freebe entitled to share in the compensation or fees received by Sponsor on terms to be negotiated by Institution and Sponsor (“Joint Revenue”). If within the Option Period, irrevocable license Sponsor desires an Exclusive License to use for its own internal noncommercial researchInstitution’s rights in such Other Invention, educational then Sponsor shall exercise this option during the Option Period and patient care purposesif an Exclusive License is executed, all Sponsor Inventions there shall be no Annual Joint Invention Report, or Other Inventions licensed or assigned to Sponsor hereunderJoint Revenues and the terms of the Exclusive License shall control. 8.5. 8.5 Nothing contained in this Agreement shall be deemed to grant either directly by implication, estoppel, or otherwise any license under any patents, patent applications, or other proprietary interest to any other inventions, discovery or improvement of either Party. 8.6. 8.6 The Parties agree that the provisions of this Agreement are intended to be interpreted and implemented so as to comply with all applicable federal laws, rules, and regulations, including without limitation the requirements of Rev. Proc. 2007-47; provided, however, if it is determined by the Internal Revenue Service or any other federal agency or instrumentality (the "Government") that the provisions of this Agreement are not in such compliance, then the Parties agree to modify the provisions and the implementation of this Agreement so as to be in compliance with all applicable federal laws, rules, and regulations as determined by the Government. 8.7 Any license granted or ownership right assigned to Sponsor shall be subject to Institution’s royalty-free, irrevocable right to use and permit other non-profit organizations to use Inventions and Other Inventions for educational and research purposes and patient care, and, if applicable, to the rights of the United States government reserved under Public Laws 96-517, 97-256 and 98-620, codified at 35 U.S.C. 200-212, and any regulations issued thereunder.

Inventions, Discoveries and Patents. 8.1. It is recognized and understood that certain existing inventions and technologies, and those arising outside of the research conducted under this Agreement, are the separate property of Sponsor Sponsor, Clinic, or Institution and are not affected by this Agreement, and neither Party Sponsor, Clinic, nor Institution shall have any claims to or rights in such separate inventions and technologies. 8.2. Any new patentable inventions, developments, or discoveries made during and in the performance of the Study (“Inventions”) shall be promptly disclosed to Sponsor. Title to Inventions that necessarily use or necessarily incorporate Sponsor’s Study Drug and/or Study Device shall reside with Sponsor (“Sponsor Inventions”). Institution Institution, Clinic, and Principal Investigator shall assign all Sponsor Inventions to Sponsor in writing. Title to Inventions other than Sponsor Inventions (“Other Inventions”) shall reside with Sponsor if Sponsor personnel are the sole inventors, with Institution if If Institution and Clinic personnel are the sole inventors, and shall be held jointly if both Institution and/or Clinic and Sponsor personnel are inventors. Institution’s, Clinic’s, and/or Principal Investigator’s obligations under Sections 8.2 and 8.3 hereunder shall be performed by its/their appropriate office(s) with technology transfer responsibilities, if required by and in accordance with Institution’s and/or Clinic’s policies. 8.3. To the extent that Institution and/or Clinic owns sole or joint title in any such Other Inventions, Sponsor is hereby granted, without option fee other than consideration of the Study sponsored herein and the reimbursement to Institution and/or Clinic for patent expenses incurred prior to or during the option period, an option to acquire an exclusive, worldwide, royalty-bearing license to Institution's ’s and Clinic’s rights to any Other Invention, which option shall extend for no more than ninety (90) days after Sponsor’s receipt of an Invention disclosure from Institution and/or Clinic (“Option Period”). The Parties Sponsor and Institution and/or Clinic shall use their reasonable efforts to negotiate, for a period not to exceed ninety (90) days after Sponsor’s exercise of such option, a license agreement satisfactory to both Parties all parties (“Negotiation Period”). In the event Sponsor fails to exercise its option within the Option Period, or the Parties Sponsor and Institution and/or Clinic fail to reach agreement on the terms of such license within the Negotiation Period, Institution and/or Clinic shall have no further obligation to Sponsor under this Agreement with regard to the specific Other Invention. 8.4. Institution and Clinic shall retain a royalty-free, irrevocable license to use for its own internal noncommercial research, educational and patient care purposes, all Sponsor Inventions or Other Inventions licensed or assigned to Sponsor hereunder. 8.5. Nothing contained in this Agreement shall be deemed to grant either directly by implication, estoppel, or otherwise any license under any patents, patent applications, or other proprietary interest to any other inventions, discovery or improvement of either PartySponsor, Institution, or Clinic. 8.6. The Parties CRO, Clinic, and Institution agree that the provisions of this Agreement are intended to be interpreted and implemented so as to comply with all applicable federal laws, rules, and regulations, including without limitation the requirements of Rev. Proc. 2007-47; provided, however, if it is determined by the Internal Revenue Service or any other federal agency or instrumentality (the "“Government"”) that the provisions of this Agreement are not in such compliance, then the Parties those parties agree to modify the provisions and the implementation of this Agreement so as to be in compliance with all applicable federal laws, rules, and regulations as determined by the Government.