Common use of TERM, TERMINATION, AND MODIFICATION OF RIGHTS Clause in Contracts

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 This Agreement is effective beginning with the Effective Date and shall extend to the expiration of the last to expire of the Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How. 12.2 In the event that Company is in default in the performance of any material obligations under this Agreement, and if the default has not been remedied within [**] days after the date of notice in writing of such default, CHOP may terminate this Agreement by written notice. 12.3 In the event that Company becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Company shall immediately notify CHOP in writing. 12.4 Company shall have a unilateral right to terminate this Agreement and/or any licenses in any country without cause by giving CHOP ninety (90) days prior written notice to that effect. 12.5 CHOP reserves the right of 35 U.S.C. §203 to terminate or modify this Agreement solely to the extent that such action is legally necessary to meet requirements of the applicable federal statutes or regulations and such requirements are not reasonably satisfied by Company. Within [**] days of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary to modify or terminate this Agreement, Company shall, if Company disagrees with such assessment, notify CHOP of such disagreement and the basis for Company’s position and this Agreement shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or by the exercise of the march-in-rights by the government. 12.6 Within [**] days of termination or expiration of this Agreement, a final report and all accrued payments shall be submitted by Company. If this Agreement is terminated under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.4.

Appears in 5 contracts

Samples: License Agreement, License Agreement (Spark Therapeutics, Inc.), License Agreement (Spark Therapeutics, Inc.)

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TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.1 This Agreement is effective beginning with when signed by all parties, unless the Effective Date provisions of Paragraph 14.15 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights or if no patents issue then for twenty (20) years from the effective date of this Agreement, unless sooner terminated as provided in this Article 1213. Upon termination expiration of the term of this Agreement pursuant Agreement, the license granted hereunder to this Article 12 as make and have made, to a Licensed Product prior use and have used, to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and have sold, to offer to sell, and to import such Licensed Product in such country under the Patent Rights, GeneMaterials shall be a royalty-Therapy Know-How free and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-Howpaid up license. 12.2 13.2 In the event that Company Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within [**] ninety (90) days after the date of notice in writing of such the default, CHOP PHS may terminate this Agreement by written noticenotice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. 12.3 13.3 In the event that Company Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Company Licensee shall immediately notify CHOP PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice upon the occurrence of any of the foregoing events. 12.4 Company 13.4 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in its entirety by giving PHS sixty (60) days written notice to that effect. In addition, Licensee shall have a unilateral right to terminate this Agreement with respect to any country without cause or territory by giving CHOP ninety PHS sixty (9060) days prior written notice to that effect. 12.5 CHOP 13.5 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if PHS determines that the Licensee: (a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, commercially reasonable steps to achieve Practical Application of the Licensed Products or Licensed Processes; (b) has not exercised commercially reasonable efforts toward achieving the Benchmarks as may be modified under Paragraph 9.2; (c) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement; (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; (f) cannot reasonably satisfy unmet health and safety needs; or (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived. 13.6 In making the determination referenced in Paragraph 13.5, PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS’ concerns as to the items referenced in 13.5(a)-13.5(g). If Licensee fails to alleviate PHS’ concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to PHS’ satisfaction, PHS may terminate this Agreement. 13.7 PHS reserves the right of according to 35 U.S.C. §203 209(d)(3) to terminate or modify this Agreement solely to if it is determined that the extent that such action is legally necessary to meet the requirements for public use specified by federal regulations issued after the date of the applicable federal statutes or regulations license and such these requirements are not reasonably satisfied by Company. Licensee. 13.8 Within [**] thirty (30) days of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary PHS’ unilateral decision to modify or terminate this Agreement, Company shallLicensee may, if Company disagrees consistent with such assessmentthe provisions of 37 CFR §404.11, notify CHOP appeal the decision by written submission to the designated PHS official. The decision of such disagreement the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and the basis for Company’s position and all administrative or judicial remedies that may be available. 13.9 Within ninety (90) days of expiration or termination of this Agreement shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or by the exercise of the march-in-rights by the government. 12.6 Within [**] days of termination or expiration of under this AgreementArticle 13, a final report and all accrued payments shall be submitted by CompanyLicensee. Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expense, due to PHS shall become immediately due and payable upon termination or expiration. If this Agreement is terminated under this Article 1213, sublicensees may elect to convert their sublicenses may be converted to the Licensed Patent Rights to direct licenses with CHOP PHS pursuant to Paragraph 4.44.3.

Appears in 4 contracts

Samples: Patent License Agreement (Mri Interventions, Inc.), Patent License Agreement (Surgivision Inc), Patent License Agreement (Surgivision Inc)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.01 This Agreement is effective beginning with the Effective Date when signed by all parties and shall extend to on a country-by-country basis until the later of (a) the expiration of the last to expire of the all royalty obligations under Licensed Patent Rights where such rights exist or have existed or (b) eight (8) years from First Commercial Sale where such rights have ceased to exist or never existed unless sooner terminated as provided in this Article 1213 or by mutual agreement of PHS and Licensee. Upon termination of this Agreement expiration pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed ProductParagraph 13.01, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company Licensee shall have a perpetualroyalty-free, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-paid up, non-royalty bearing, perpetual, unrestricted right transferrable perpetual license to use the Patent Rights, Gene-Therapy Know-How Biological Materials transferred hereunder in the Licensed Territories and Know-Howall derivatives and products made by Licensee therefrom. 12.2 13.02 In the event that Company Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.05, and if the default has not been remedied within [**] ninety (90) days after the date of notice in writing of such default, CHOP PHS may terminate this Agreement by written noticenotice and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Act. 12.3 13.03 In the event that Company Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Company Licensee shall immediately notify CHOP PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon written notice to Licensee, given the understanding that PHS shall first endeavor in good faith to assist Licensee in any efforts to emerge from bankruptcy by maintaining the present License in effect for a reasonable period of time not to exceed one (1) year from Licensee’s receipt of written notice, unless otherwise deemed necessary to address an immediate public health need. 12.4 Company 13.04 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country without cause or territory by giving CHOP ninety PHS sixty (9060) days prior written notice to that effect. 12.5 CHOP reserves 13.05 PHS shall specifically have the right of 35 U.S.C. §203 to terminate or modify this Agreement solely to the extent that such action is legally necessary to meet requirements of the applicable federal statutes or regulations and such requirements are not reasonably satisfied by Company. Within [**] days of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary to modify or terminate modify, at its option, this Agreement, Company shall, if Company disagrees PHS determines that the Licensee: 1) is not executing the Commercial Development Plan consistent with such assessment, notify CHOP the requirement of such disagreement Paragraph 10.01 and the basis for CompanyLicensee cannot otherwise demonstrate to PHS’s position reasonable satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.02, and this Agreement shall the Licensee cannot otherwise demonstrate to PHS’s reasonable satisfaction that the Licensee has taken, or can be terminated expected to take within a reasonable time, effective steps to correct the failure to achieve the relevant Benchmark in order to achieve the relevant Benchmark within the earliest reasonably possible time; 3) has willfully made a false statement of, or modified unless and until such disagreement is resolved willfully omitted, a material fact in accordance with Paragraph 13.12 the license application or in any report required by the exercise license Agreement; 4) has committed a material breach of the march-in-rights by the government. 12.6 Within [**] days of termination a covenant or expiration of this Agreement, a final report and all accrued payments shall be submitted by Company. If this Agreement is terminated under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.4.agreement

Appears in 2 contracts

Samples: Patent License Agreement (Aridis Pharmaceuticals, Inc.), Patent License Agreement (Aridis Pharmaceuticals, Inc.)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.1 This Agreement is effective beginning with when signed by all parties, unless the Effective Date provisions of Paragraph 14.15 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How13. 12.2 13.2 In the event that Company the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within [**] ninety (90) days after the date of notice in writing of such the default, CHOP the NIAID may terminate this Agreement by written notice.notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act; provided, however, that if the Licensee disputes in good faith that it has defaulted in its performance of any material obligation under this Agreement or that any such default has not been timely remedied, the NIAID and the Licensee shall negotiate promptly and in good faith to resolve such dispute [***]. [***] NIH Patent License Agreement Nonexclusive - Sublicensable 12.3 13.3 In the event that Company the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Company the Licensee shall immediately notify CHOP the NIAID in writing. 12.4 Company 13.4 The Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country without cause or territory by giving CHOP ninety the NIAID sixty (9060) days prior written notice to that effect. 12.5 CHOP 13.5 The NIAID shall specifically have the right to terminate or modify, at its option, this Agreement, if the NIAID reasonably determines that the Licensee, its Affiliate(s), or sublicensees: (a) is not executing the Commercial Development Plan submitted with its request for a license, as amended pursuant to Paragraph 9.2, and the Licensee cannot otherwise demonstrate to the NIAID’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; (b) has not achieved the Benchmarks in at least one of the indications identified in Appendix D as may be modified under Paragraph 9.2; (c) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement; (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping at least one Licensed Product or Licensed Process reasonably available to the public in the U.S. after commercial use commences; or (f) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived. [***] NIH Patent License Agreement Nonexclusive - Sublicensable 13.6 In making the determination referenced in Paragraph 13.5, the NIAID shall take into account the normal course of such commercial development and manufacturing programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the NIAID shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the NIAID’s concerns as to the items referenced in 13.5(a)-13.5(f). If the Licensee fails to alleviate the NIAID’s concerns as to the items referenced in 13.5(a)-13.5(f) or fails to develop a corrective action plan and initiate corrective action pursuant to such plan to the NIAID’s reasonable satisfaction, the NIAID may terminate this Agreement upon written notice to the Licensee; provided, however, that if the Licensee disputes in good faith the NIAID’s determination with respect to any item(s) referenced in 13.5(a)-13.5(f), the NIAID and the Licensee shall negotiate promptly and in good faith to resolve such dispute. 13.7 The NIAID reserves the right of according to 35 U.S.C. §203 209(d)(3) to terminate or modify this Agreement solely to if it is determined that the extent that such action is legally necessary to meet the requirements for public use specified by federal regulations issued after the date of the applicable federal statutes or regulations license and such these requirements are not reasonably satisfied by Company. the Licensee. 13.8 Within [**] thirty (30) days of receipt of written notice of CHOPthe NIAID’s belief or notification from the government that it is legally necessary unilateral decision to modify or terminate this Agreement, Company shallthe Licensee may, if Company disagrees consistent with such assessmentthe provisions of 37 CFR §404.11, notify CHOP appeal the decision by written submission to the designated NIAID official. The decision of such disagreement the designated NIAID official shall be the final agency decision. The Licensee may thereafter exercise any and the basis for Company’s position and all administrative or judicial remedies that may be available. 13.9 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or submitted by the exercise of Licensee. Any royalty payments, including those incurred but not yet paid (such as the march-in-rights by minimum annual royalty), and those related to patent expense, due to the government. 12.6 Within [**] days of NIAID shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with the NIAID pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, a the Licensee shall return all Licensed Products provided by the NIAID or other NIAID-provided materials included within the Licensed Patent Rights to the NIAID or provide the NIAID with written certification of the destruction thereof. The Licensee may not be granted additional NIAID licenses if the final report and all accrued payments shall be submitted by Companyreporting requirement is not fulfilled. If this [***] NIH Patent License Agreement is terminated under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.4.Nonexclusive - Sublicensable

Appears in 2 contracts

Samples: Patent License Agreement (Icosavax, Inc.), Patent License Agreement Nonexclusive – Sublicensable (Icosavax, Inc.)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.1 This Agreement is effective beginning when signed by all parties, is subject to termination in accordance with all other relevant provisions hereof, shall continue in force for an initial period of _____ (____) years, and thereafter the Effective Date and shall agreement will automatically extend to the expiration for consequent periods of ____ (____) years unless terminated by one of the last to expire parties with _____ (____) months written notice of the Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-Howtermination. 12.2 13.2 In the event that Company Taconic is in default in the performance of any material obligations under this Agreement, and if the default has not been remedied within [**] thirty (30) days after the date of notice in writing of such the default, CHOP Samaritan may terminate this Agreement by written notice. 12.3 13.3 In the event that Company Taconic becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Company Taconic shall immediately notify CHOP Samaritan in writing. Furthermore, Samaritan shall have the right to terminate this Agreement immediately upon Taconic’s receipt of written notice. 12.4 Company 13.4 Taconic shall have a unilateral right to terminate this Agreement and/or any licenses in any country without cause or territory by giving CHOP Samaritan ninety (90) days prior written notice to that effect, provided Taconic has paid all royalties owed to Samaritan. 12.5 CHOP reserves the right 13.5 Within ninety (90) days of 35 U.S.C. §203 to terminate expiration or modify termination of this Agreement solely under this Article 13, a final report shall be submitted by Taconic. Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to the extent that such action is legally necessary patent expense, due to meet requirements of the applicable federal statutes Samaritan shall become immediately due and payable upon termination or regulations and such requirements are not reasonably satisfied by Companyexpiration. Within [**] days of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary to modify or terminate Unless otherwise specifically provided for under this Agreement, Company shall, if Company disagrees with such assessment, notify CHOP of such disagreement and the basis for Company’s position and this Agreement shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or by the exercise of the march-in-rights by the government. 12.6 Within [**] days of upon termination or expiration of this Agreement, a final report and Taconic shall return all accrued payments Licensed Products or other materials included within the Licensed Patent Rights to Samaritan or provide Samaritan with written certification of the destruction thereof. 13.6 Samaritan shall be submitted by Company. If have the right to terminate this Agreement is terminated under this Article 12, sublicenses may be converted agreement after 60 days notice to direct licenses with CHOP pursuant to Paragraph 4.4Taconic after the second anniversary of the Effective Date in any year that Taconic does not reach minimum annual revenues of USD ________.

Appears in 2 contracts

Samples: Patent and Trademark License Agreement, Patent and Trademark License Agreement (Samaritan Pharmaceuticals Inc)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.01 This Agreement is effective beginning with as of the Effective Date and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How13. 12.2 13.02 In the event that Company Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Article 13.05, and if the default has not been remedied within [**] ninety (90) days after the date of notice in writing of such default, CHOP PHS may terminate this Agreement by written noticenotice and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Act. 12.3 13.03 In the event that Company Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third partyparry’s intention to file an involuntary petition in bankruptcy, Company Licensee shall immediately notify CHOP PHS in writing. PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of such written notice. 12.4 Company 13.04 Notwithstanding anything to the contrary in this Agreement, Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country without cause or territory by giving CHOP ninety PHS sixty (9060) days prior written notice to that effecteffect In such event. Licensee will not have any obligations whatsoever to PHS, other than for payments that should have been paid by Licensee to PHS prior to the date of the notice of termination. 12.5 CHOP reserves 13.05 PHS shall specifically have the right of 35 U.S.C. §203 to terminate or modify this Agreement solely to the extent that such action is legally necessary to meet requirements of the applicable federal statutes or regulations and such requirements are not reasonably satisfied by Company. Within [**] days of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary to modify or terminate modify, at its option, this Agreement, Company shall, if Company disagrees with such assessment, notify CHOP PHS determines that per the submission incorporated in Appendix F of such disagreement and the basis for Company’s position and this Agreement shall the Licensee: 1) is not be terminated or modified unless and until such disagreement is resolved in accordance executing the Commercial Development Plan of Appendix F with Paragraph 13.12 or by the exercise of the march-in-rights by the government. 12.6 Within [**] days of termination or expiration of this Agreement, a final report and all accrued payments shall be submitted by Company. If this Agreement is terminated under this Article 12, sublicenses may be converted due diligence subject to direct licenses with CHOP any amendment thereto pursuant to Paragraph 4.49.02; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement; 4) has committed a material breach of a covenant or agreement contained in under this Agreement; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; 6) cannot reasonably satisfy unmet health and safety needs; 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.02 unless waived. In making this determination, PHS will take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.

Appears in 2 contracts

Samples: Patent License Agreement (Brainsway Ltd.), Patent License Agreement (Brainsway Ltd.)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.1 This Agreement is effective beginning with when signed by all parties, (the Effective Date Date”), and shall extend to the expiration of the last to expire of (a) the Licensed Patent Rights and (b) the U.S. Orphan Drug Exclusivity, European Orphan Drug Exclusivity, Australian Orphan Drug Exclusivity, Japanese Orphan Drug Exclusivity or equivalent foreign Orphan Drug Exclusivity with respect to any Licensed Product, unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How6 or 13. 12.2 13.2 In the event that Company the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within [***] ([***]) days after the date of notice in writing of such the default, CHOP the IC may terminate this Agreement by written noticenotice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. 12.3 13.3 In the event that Company the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third partyThird Party’s intention to file an involuntary petition in bankruptcy, Company the Licensee shall immediately notify CHOP the IC in writing. 12.4 Company 13.4 The Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country without cause or territory by giving CHOP ninety the IC sixty (9060) days prior written notice to that effect. 12.5 CHOP 13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee: (a) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement; (b) has committed a material breach of a covenant or agreement contained in this Agreement; (c) is not keeping Licensed Products or Licensed Processes reasonably available to the public after First Commercial Sale; (d) cannot reasonably satisfy unmet health and safety needs; or (e) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived. 13.6 In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a [***] ([***]) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement. 13.7 The IC reserves the right of according to 35 U.S.C. §203 209(d)(3) to terminate or modify this Agreement solely to if it is determined that the extent that such action is legally necessary to meet the requirements for public use specified by federal regulations issued after the date of the applicable federal statutes or regulations license and such these requirements are not reasonably satisfied by Company. the Licensee. 13.8 Within [***] ([***]) days of receipt of written notice of CHOPthe IC’s belief or notification from the government that it is legally necessary unilateral decision to modify or terminate this Agreement, Company shallthe Licensee may, if Company disagrees consistent with such assessmentthe provisions of 37 CFR §404.11, notify CHOP of such disagreement and appeal the basis for Company’s position and this Agreement shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or decision by written submission to the exercise designated the IC official. The decision of the march-in-rights by designated IC official shall be the governmentfinal agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 12.6 13.9 Within [***] ([***]) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by the Licensee. Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expense, due to the IC shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, Sublicensees may elect to convert their sublicenses to direct licenses with the IC pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, a the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to the IC or provide the IC with written certification of the destruction thereof. The Licensee may not be granted additional the IC licenses if the final report and all accrued payments shall be submitted by Company. If this Agreement reporting requirement is terminated under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.4not fulfilled.

Appears in 1 contract

Samples: Patent License Agreement (LogicBio Therapeutics, Inc.)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 This 14.01 The term of this Agreement is effective beginning with as of the Effective Date and shall extend to the expiration of the last to expire of claim contained in the Licensed Patent Rights (the “Term”) unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How14. 12.2 14.02 In the event that Company OXIQUANT is in default in the performance of any material obligations under this Agreement, and if the default has not been remedied within [**] sixty (60) days after the date of notice in writing from OHSU to OXIQUANT of such default, CHOP OHSU may terminate the Term by written notice to OXIQUANT. 14.03 OXIQUANT may, upon sixty (60) days written notice to OHSU, terminate this Agreement by written noticedoing all of the following: a) Ceasing to make, have made, use, import, sell and offer for sale any Licensed Products and/or use of Licensed Processes; b) Terminating all sublicenses, and causing all sublicensees to cease making, having made, using, importing, selling and offering for sale any Licensed Products and/or use of Licensed Processes; and c) Paying all monies owed to OHSU under this Agreement. 12.3 In 14.04 OHSU shall specifically have the event that Company becomes insolventright, files a petition in bankruptcybut not the obligation, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Company shall immediately notify CHOP in writing. 12.4 Company shall have a unilateral right to terminate this Agreement and/or if OHSU determines that: 1) OXIQUANT is more than sixty (60) days late in paying to OHSU any licenses consideration due under this Agreement and OXIQUANT does not immediately pay OHSU in any country without cause by giving CHOP full upon OHSU’s written demand, 2) OXIQUANT experiences a Trigger Event, or 3) OXIQUANT materially breaches this Agreement (other than a breach solely under 14.04 (1)) and does not cure the breach within sixty (60) days after written notice of the breach. 14.05 Within ninety (90) days prior written notice to that effect. 12.5 CHOP reserves the right of 35 U.S.C. §203 to terminate expiration or modify termination of this Agreement solely to the extent that such action is legally necessary to meet requirements of the applicable federal statutes or regulations and such requirements are not reasonably satisfied by Company. Within [**] days of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary to modify or terminate under this Agreement, Company shall, if Company disagrees with such assessment, notify CHOP of such disagreement and the basis for Company’s position and this Agreement shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or by the exercise of the march-in-rights by the government. 12.6 Within [**] days of termination or expiration of this AgreementArticle 14, a final report and all accrued payments shall be submitted by CompanyOXIQUANT. Any royalty payments, including those related to patent expense, due to OHSU shall become immediately due and payable upon termination or expiration. If this Agreement is terminated under this Article 1214, sublicensees may elect to convert their sublicenses may be converted to direct licenses with CHOP pursuant OHSU subject to Paragraph 4.44.03. 14.06 Upon termination of this Agreement, OXIQUANT and any sublicensee shall, at OHSU’s request, return to OHSU any data generated during the term of this Agreement that will facilitate the development of the technology licensed under this Agreement, provided, however, that OXIQUANT may keep one copy for archival purposes only. 14.07 Upon termination of this Agreement, OXIQUANT shall cause physical inventories to be taken immediately of: (a) all completed Licensed Product(s) on hand under the control of OXIQUANT or any Affiliate or sublicensee; and (b) such Licensed Product(s) as are in the process of manufacture and component parts thereof as of the date of termination of this Agreement, which inventories shall be reduced to writing. OXIQUANT shall deliver copies of such written inventories, verified by an officer of OXIQUANT forthwith to OHSU. OHSU shall have 45 days after receipt of such verified inventories within which to challenge the inventory and request an audit. Upon five days written notice to OXIQUANT, OHSU and its agents shall be given access during business hours to the premises of OXIQUANT or its Affiliates or sublicensees for the purpose of conducting an audit. Upon the termination of this Agreement, OXIQUANT shall, at its own expense forthwith remove, efface or destroy all references to OHSU from all advertising or other materials used in the promotion of OXIQUANT’s business or the business of any Affiliate or sublicensee and OXIQUANT and any Affiliate or sublicensee shall not thereafter represent in any manner that it has rights in or to the Licensed Patent Rights or Licensed Product(s) or Licensed Processes. 14.08 Notwithstanding the foregoing, OXIQUANT shall have a period of six (6) months after termination to sell off its inventory of Licensed Product(s) existing on the date of termination of this Agreement and shall pay royalties to OHSU with respect to such Licensed Product(s) within thirty (30) days following the expiration of such six-month period (“Sell Off Right”). 14.09 Paragraphs 4.03, 4.05, 6.04-6.08, 7.02, 7,05, 7.06, 9.01, 10.04, 12.01-12.08, 13.01-13.03, 14.05-14.09, 15.01 and 17.01-17.12 of this Agreement shall survive termination of this Agreement. OXIQUANT’s obligation to pay all monies owed accruing under this Agreement shall survive termination of this Agreement.

Appears in 1 contract

Samples: Exclusive License Agreement (Adherex Technologies Inc)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.01 This Agreement is effective beginning with as of the Effective Date and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How13. 12.2 13.02 In the event that Company Licensee is in default in the performance of any material Material obligations under this Agreement, and if the default has not been remedied within [**] sixty (60) days after the date of Of notice in writing of such default, CHOP OHSU may terminate this Agreement by written notice. 12.3 In 13.03 Licensee may, upon sixty (60) days written notice to OHSU, terminate this Agreement by doing all of the event that Company becomes insolventfollowing: a) Ceasing to make, files a petition in bankruptcyhave made, has such a petition filed against ituse, determines import, sell and offer for sale any Licensed Products and/or use of Licensed Processes; b) Terminating all sublicenses, and causing all sublicensees to file a petition in bankruptcycease making, or receives notice having made, using, importing, selling and offering for sale any Licensed Products and/or use of a third party’s intention Licensed Processes; and c) Paying all monies owed to file an involuntary petition in bankruptcy, Company OHSU under this Agreement 13.04 OHSU shall immediately notify CHOP in writing. 12.4 Company shall specifically have a unilateral the right to terminate this Agreement and/or if OHSU determines that: 1) Licensee is more than thirty (30) days late in paying to OHSU any licenses consideration due under this Agreement and Licensee does not immediately pay OHSU in any country without cause by giving CHOP full upon demand, 2) Licensee experiences a Trigger Event, or 3) Licensee breaches this Agreement (other than a breach solely under 13.04 (1)1 and does not cure the breach within sixty (60) days after written notice of the breach. 13.05 OHSU shall specifically have the right to terminate or modify, at its option, this Agreement, if OHSU determines that the Licensee: 1) is not reasonably proceeding with the development and practical application of Licensed Products or Licensed Processes and the Licensee cannot otherwise demonstrate to OHSU’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve practical application of the Licensed Products or Licensed Processes; or 2) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences. In making this determination, OHSU will take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment. Prior to invoking this right, OHSU shall give written notice to Licensee providing Licensee specific notice of, and a sixty (60) day opportunity to respond to, OHSU’s concerns as to the previous items 1) to 3). If Licensee fails to alleviate OHSU’s concerns as to the previous items 1) to 3) or fails to initiate corrective action to OHSU’s satisfaction, OHSU may terminate or modify this Agreement. 13.06 Within ninety (90) days prior written notice to that effect. 12.5 CHOP reserves the right of 35 U.S.C. §203 to terminate expiration or modify termination of this Agreement solely to the extent that such action is legally necessary to meet requirements of the applicable federal statutes or regulations and such requirements are not reasonably satisfied by Company. Within [**] days of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary to modify or terminate under this Agreement, Company shall, if Company disagrees with such assessment, notify CHOP of such disagreement and the basis for Company’s position and this Agreement shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or by the exercise of the march-in-rights by the government. 12.6 Within [**] days of termination or expiration of this AgreementArticle 13, a final report and all accrued payments shall be submitted by CompanyLicensee. Any royalty payments, including those related to patent expense, due to OHSU shall become immediately due and payable upon termination or expiration. If this Agreement is terminated under this Article 1213, sublicensees may elect to convert their sublicenses may be converted to direct licenses with CHOP OHSU pursuant to Paragraph 4.44.04. 13.07 Upon termination of this Agreement, Licensee and any sublicensee shall, at OHSU’s request, return to OHSU any data generated during the term of this Agreement that will facilitate the development of the technology licensed under this Agreement. 13.08 Upon termination of this Agreement, Licensee shall cause physical inventories to be taken immediately of: (a) all completed Licensed Products) or products requiring the use of Licensed Processes on hand under the control of Licensee or any sublicensee; and (b) such Licensed Product(s) or products as are in the process of manufacture and component parts thereof as of the date of termination of this Agreement, which inventories shall be reduced to writing. Licensee shall deliver copies of such written inventories, verified by an officer of Licensee forthwith to OHSU. OHSU shall have 46 days after receipt of such verified inventories within which to challenge the inventory and request an audit. Upon five days written notice to Licensee, OHSU and its agents shall be given access during business hours to the premises of Licensee or its sublicensees for the purpose of conducting an audit. Upon the termination of this Agreement, Licensee shall, at its own expense forthwith remove, efface or destroy all references to OHSU from all advertising or other materials used in the promotion of Licensee’s business or the business of any sublicensee and Licensee and any sublicensee shall not thereafter represent in any manner that it has rights in or to the Licensed Patent Rights or Licensed Product(s) or products requiring the use of Licensed Process(es). 13.09 Notwithstanding the foregoing, if this Agreement terminates other than pursuant to Paragraph 13.04 1) or 2), Licensee shall have a period of six (6) months to sell off its inventory of Licensed Product(s) or products requiring the use of Licensed Process(es) existing on the date of termination of this Agreement and shall pay royalties to OHSU with respect to such Licensed Product(s) and products within thirty (30) days following the expiration of such six-month period (“Sell Off Right”). 13.10 Paragraphs 4.06, 6.06, 6.07, 8.01, 9.07, 12.01-12,05, 13.06-13.10, and 14.12 of this Agreement shall survive termination of this Agreement. Licensee’s obligation to pay all monies owed accruing under this Agreement shall survive termination of this Agreement.

Appears in 1 contract

Samples: Exclusive License Agreement

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.1 This Agreement is effective beginning with on August 1, 2015 (the Effective Date Date”), only after being signed by all parties, unless the provisions of Paragraph 14.16 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How13. 12.2 13.2 In the event that Company the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within [**] ninety (90) days after the date of notice in writing of such the default, CHOP the NIH may terminate this Agreement by written noticenotice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. 12.3 13.3 In the event that Company the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s 's intention to file an involuntary petition in bankruptcy, Company the Licensee shall immediately notify CHOP the NIH in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee's receipt of written notice. A-360-2014 NIH Patent License Agreement--Exclusive Model 10-2005 (updated 8-2012) Page 9 of 21 [GlobeImmune, Inc.] [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 12.4 Company 13.4 The Licensee shall have a unilateral right to terminate this Agreement and/or or any licenses in any country without cause or territory by giving CHOP ninety the NIH sixty (9060) days prior written notice to that effect. 12.5 CHOP 13.5 The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, pursuant to Paragraph 13.2, if the NIH determines that the Licensee: (a) is not executing the Commercial Development Plan pursuant to its obligations under Paragraph 10.1 and the Licensee cannot otherwise demonstrate to the NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes; (b) has not achieved the Benchmarks as may be modified under Paragraph 9.2; (c) has willfully made a false statement of, or willfully omitted a material fact in the license application or in any report required by this Agreement; (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping the Licensed Products or the Licensed Processes reasonably available to the public after commercial use commences; (f) cannot, after First Commercial Sale, reasonably satisfy unmet health and safety needs; or (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 13.6 In making the determination referenced in Paragraph 13.5, the NIH shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the NIH’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the NIH’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the NIH’s satisfaction, the NIH may terminate this Agreement. 13.7 When the public health and safety so require, and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, the NIH shall have the right to require the Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless the Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. The NIH shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee. 13.8 The NIH reserves the right of according to 35 U.S.C. §203 209(d)(3) to terminate or modify this Agreement solely to the extent if it is determined that such this action is legally necessary to meet the requirements for public use specified by federal regulations issued after the date of the applicable federal statutes or regulations license and such these requirements are not reasonably satisfied by Company. the Licensee. 13.9 Within [**] thirty (30) days of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary NIH's unilateral decision to modify or terminate this Agreement, Company shallthe Licensee may, if Company disagrees consistent with such assessmentthe provisions of 37 C.F.R. §404.11, notify CHOP appeal the decision by written submission to the designated NIH official. The decision of such disagreement the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any and the basis for Company’s position and all administrative or judicial remedies that may be available. 13.10 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or submitted by the exercise of Licensee. Any royalty payments, including those incurred but not yet paid (such as the march-in-rights by the government. 12.6 Within [**] days of royalty), and those related to patent expenses, due to the NIH shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with the NIH pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, a the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to the NIH or provide the NIH with certification of the destruction thereof. The Licensee may not be granted additional NIH licenses if the final report and all accrued payments shall be submitted by Company. If this Agreement reporting requirement is terminated under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.4not fulfilled.

Appears in 1 contract

Samples: Patent License Agreement (Globeimmune Inc)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.01 This Agreement is effective beginning with as of the Effective Date and shall extend to the expiration of the last to expire of the Patent Rights or the royalty term defined in Section 6.03.3 unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How13. 12.2 13.02 In the event that Company LICENSEE is in default in the performance of any material obligations under this Agreement, and if the default has not been remedied within [***] ([***]) days after the date of notice in writing of such default, CHOP OHSU may terminate this Agreement by written notice. 12.3 13.03 In the event that Company LICENSEE becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Company LICENSEE shall immediately notify CHOP OHSU in writing. Furthermore, OHSU shall have the right to *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. terminate this Agreement by giving LICENSEE written notice. Termination of this Agreement is effective upon LICENSEE’s receipt of the written notice. 12.4 Company 13.04 LICENSEE shall have a unilateral right to terminate this Agreement and/or any licenses in any country without cause by giving CHOP ninety OHSU [***] (90[***]) days prior written notice to that effect. 12.5 CHOP reserves 13.05 OHSU shall have the right of 35 U.S.C. §203 to terminate or modify modify, at its option, this Agreement solely if LICENSEE (a) cannot demonstrate to OHSU’s satisfaction that LICENSEE has taken, or can be expected to take within a reasonable time, effective steps to achieve practical application of the Licensed Products, Screening Products or Licensed Processes under Article 9; (b) has willfully made a false statement of, or willfully omitted, a material fact in any report required by the license agreement; or (c) has committed a substantial breach of a covenant or agreement contained in the license. 01. Prior to invoking this right, OHSU shall give written notice to LICENSEE providing LICENSEE specific notice of, and a [***] ([***]) day opportunity to respond to, OHSU’s concerns as to the extent that such previous items (a) to (c). If LICENSEE fails to alleviate OHSU’s concerns as to the previous items (a) to (c) or fails to initiate corrective action is legally necessary to meet requirements of the applicable federal statutes or regulations and such requirements are not reasonably satisfied by Company. OHSU’s satisfaction, OHSU may terminate this Agreement. 13.06 Within [***] days of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary to modify or terminate this Agreement, Company shall, if Company disagrees with such assessment, notify CHOP of such disagreement and the basis for Company’s position and this Agreement shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or by the exercise of the march-in-rights by the government. 12.6 Within ([**] *]) days of termination of this Agreement under this Article 13, a final report shall be submitted by LICENSEE. Any royalty payments, including those related to patent expenses, due to OHSU shall become immediately due and payable upon termination or expiration expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with OHSU pursuant to Paragraph 4.03. 13.07 Upon termination of this Agreement, a final report LICENSEE shall, at its own expense, forthwith remove, efface or destroy all references to OHSU from all advertising or other materials used in the promotion of LICENSEE’s business or sublicensees and LICENSEE or sublicensees shall not thereafter represent in any manner that it has rights in or to the Patent Rights, Licensed Products, Screening Products, or Licensed Processes. 13.08 Immediately upon termination, LICENSEE agrees to return all accrued payments shall be submitted by Company. If MICE to OHSU, or to destroy said MICE and certify in writing to OHSU that MICE have been destroyed. 13.09 Paragraphs 4.03, 7.01, 8.04, 12.01-12.05, and 14.11 of this Agreement is terminated under shall survive termination of this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.4Agreement.

Appears in 1 contract

Samples: License Agreement (Orexigen Therapeutics, Inc.)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.1 This Agreement is effective beginning with when signed by all parties, unless the Effective Date provisions of Paragraph 14.16 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How13. 12.2 13.2 In the event that Company the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, IC shall give written notice to the Licensee and if a ninety (90) day period to remedy the default. If the Licensee fails to take substantive steps to remedy the default has not been remedied to the IC’s satisfaction within [**] days after such ninety (90) day period, the date of notice in writing of such default, CHOP IC may terminate this Agreement by written noticenotice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. 12.3 13.3 In the event that Company the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s 's intention to file an involuntary petition in bankruptcy, Company the Licensee shall immediately notify CHOP the IC in writing. 12.4 Company 13.4 The Licensee shall have a unilateral right to terminate this Agreement and/or or any licenses in any country without cause or territory by giving CHOP ninety the IC sixty (9060) days prior written notice to that effect. 12.5 CHOP reserves 13.5 The IC shall specifically have the right of 35 U.S.C. §203 to terminate or modify modify, at its option, this Agreement, if the IC determines that the Licensee: (a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes; (b) has not achieved the Benchmarks as may be modified under Paragraph 9.2; (c) has willfully made a false statement of, or willfully omitted a material fact in the license application or in any report required by this Agreement; A-034-2016 NIH Patent License Agreement—Exclusive PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping the Licensed Products or the Licensed Processes reasonably available to the public after commercial use commences; (f) cannot reasonably satisfy unmet health and safety needs; or (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 13.6 In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement solely under Paragraph 13.5, the IC shall give written notice to the extent that such Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action is legally necessary to meet requirements of the applicable federal statutes or regulations and such requirements are not reasonably satisfied by Company. Within [**] days of receipt of written notice of CHOPIC’s belief or notification from satisfaction, the government that it is legally necessary to modify or IC may terminate this Agreement. 13.7 When the public health and safety so require and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, Company shallthe IC shall have the right to require the Licensee to grant sublicenses to responsible applicants, if Company disagrees with such assessmenton commercially reasonable terms, notify CHOP in any Licensed Fields of such disagreement and Use under the basis for Company’s position and this Agreement shall not be terminated or modified Licensed Patent Rights, unless and until such disagreement is resolved in accordance with Paragraph 13.12 or by the exercise Licensee can reasonably demonstrate that the granting of the march-in-rights by sublicense would not materially increase the government. 12.6 Within [**] days availability to the public of termination or expiration the subject matter of this Agreement, a final report and all accrued payments shall be submitted by Company. If this Agreement is terminated under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.4.the

Appears in 1 contract

Samples: Patent License Agreement (Scopus BioPharma Inc.)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.01 This Agreement is effective beginning with when signed by the Effective Date Parties, except that the noncreditable, nonrefundable licensee issue royalty fee in the amount of Eighty-Five Thousand Eight Hundred and Fifty-Eight Dollars and Fifty-Four Cents ($85,858.54 U.S. Dollars) for outstanding patent prosecution costs owed to PHS under this Agreement will be held in escrow by Licensee until the execution of a release agreements) by PSU and UC that is substantially similar to the Release Agreement attached hereto as Appendix I, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How13. 12.2 13.02 In the event that Company Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Article 13.05, and if the default has not been remedied within [**] ninety (90) days after the date of on which License receives notice in writing of such default, CHOP PHS may terminate this Agreement by written noticenotice and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Act. 12.3 13.03 In the event that Company tat Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Company Licensee shall immediately notify CHOP PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice. 12.4 Company 13.04 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country without cause or territory by giving CHOP ninety PHS sixty (9060) days prior written notice to that effect. 12.5 CHOP reserves 13.05 PHS shall specifically have the right of 35 U.S.C. §203 to terminate or modify this Agreement solely to the extent that such action is legally necessary to meet requirements of the applicable federal statutes or regulations and such requirements are not reasonably satisfied by Company. Within [**] days of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary to modify or terminate modify, at its option, this Agreement, Company shallif PHS determines that the Licensee: 1) is not using its commercially reasonable best efforts to execute the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’ reasonable satisfaction that the Licensee has taken, if Company disagrees or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; 2) has not used its commercially reasonable best efforts to achieve the Benchmarks as may be modified under Paragraph 9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by the license Agreement; 4) has committed a material breach of a covenant or agreement contained in the license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; 6) cannot reasonably satisfy unmet health and safety needs; or 7) cannot reasonably justify a failure to comply with such assessmentthe domestic production requirement of Paragraph 5.02 unless waived. In making this determination, notify CHOP PHS will take into account the normal course of such disagreement commercial development programs conducted with sound and reasonable business practices and judgment and the basis for Company’s position and this Agreement shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or by the exercise of the march-in-rights by the government. 12.6 Within [**] days of termination or expiration of this Agreement, a final report and all accrued payments shall be annual reports submitted by Company. If this Agreement is terminated Licensee under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.49.

Appears in 1 contract

Samples: Patent License Agreement (Keryx Biopharmaceuticals Inc)

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TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.01 This Agreement is effective beginning with when signed by the Effective Date Parties, except that the noncreditable, nonrefundable licensee issue royalty fee in the amount of Eighty-Five Thousand Eight Hundred and Fifty-Eight Dollars and Fifty-Four Cents ($85,858.54 U.S. Dollars) for outstanding patent prosecution costs owed to PHS under this Agreement will be held in escrow by Licensee until the execution of a release agreement(s) by PSU and UC that is substantially similar to the Release Agreement attached hereto as Appendix I, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How13. 12.2 13.02 In the event that Company Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Article 13.05, and if the default has not been remedied within [**] ninety (90) days after the date of on which License receives notice in writing of such default, CHOP PHS may terminate this Agreement by written noticenotice and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Act. 12.3 13.03 In the event that Company Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Company Licensee shall immediately notify CHOP PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice. 12.4 Company 13.04 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country without cause or territory by giving CHOP ninety PHS sixty (9060) days prior written notice to that effect. 12.5 CHOP reserves 13.05 PHS shall specifically have the right of 35 U.S.C. §203 to terminate or modify this Agreement solely to the extent that such action is legally necessary to meet requirements of the applicable federal statutes or regulations and such requirements are not reasonably satisfied by Company. Within [**] days of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary to modify or terminate modify, at its option, this Agreement, Company shallif PHS determines that the Licensee: 1) is not using its commercially reasonable best efforts to execute the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’ reasonable satisfaction that the Licensee has taken, if Company disagrees or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; 2) has not used its commercially reasonable best efforts to achieve the Benchmarks as may be modified under Paragraph 9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by the license Agreement; 4) has committed a material breach of a covenant or agreement contained in the license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; 6) cannot reasonably satisfy unmet health and safety needs; or 7) cannot reasonably justify a failure to comply with such assessmentthe domestic production requirement of Paragraph 5.02 unless waived. In making this determination, notify CHOP PHS will take into account the normal course of such disagreement commercial development programs conducted with sound and reasonable business practices and judgment and the basis for Company’s position and this Agreement shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or by the exercise of the march-in-rights by the government. 12.6 Within [**] days of termination or expiration of this Agreement, a final report and all accrued payments shall be annual reports submitted by Company. If this Agreement is terminated Licensee under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.49.

Appears in 1 contract

Samples: Patent License Agreement (Paligent Inc)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.1 This Agreement is effective beginning with when signed by all parties, unless the Effective Date provisions of Paragraph 14.16 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How13. 12.2 13.2 In the event that Company the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within [***] days after the date of notice in writing of such the default, CHOP the NIH may terminate this Agreement by written noticenotice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. 12.3 13.3 In the event that Company the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s 's intention to file an involuntary petition in bankruptcy, Company the Licensee shall immediately notify CHOP the NIH in writing. 12.4 Company 13.4 The Licensee shall have a unilateral right to terminate this Agreement and/or or any licenses in any Licensed Fields of Use in any country without cause or territory by giving CHOP ninety (90) days prior the NIH [***] written notice to that effect. A-107-2014 NIH Patent License Agreement--Exclusive CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 12.5 CHOP 13.5 The NIH shall specifically have the right to terminate or modify, at its option, this Agreement by written notice to the Licensee, if the NIH reasonably determines that the Licensee: (a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes; (b) has not achieved the Benchmarks as may be modified under Paragraph 9.2; (c) has willfully made a false statement of, or willfully omitted a material fact in the license application or in any report required by this Agreement; (d) has committed a material breach of a covenant or agreement contained in this Agreement that has not been remedied within the [***] period set forth in Paragraph 13.2 above; (e) is not keeping the Licensed Products or the Licensed Processes reasonably available to the public after commercial use commences; (f) cannot reasonably satisfy unmet health and safety needs; (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 13.6 In making the determination referenced in Paragraph 13.5, the NIH shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a [***] opportunity to respond to, the NIH’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the NIH’s concerns as to the items referenced in 13.5(a)-13.5(g) or within [***] following written notice from the NIH or otherwise fails to initiate corrective action to the NIH’s satisfaction, the NIH may terminate this Agreement upon written notice to the Licensee. 13.7 When the public health and safety so require, and after written notice to the Licensee providing the Licensee a [***] opportunity to respond, the NIH shall have the right to require the Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless the Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. The NIH shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee. A-107-2014 NIH Patent License Agreement--Exclusive CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 13.8 The NIH reserves the right of according to 35 U.S.C. §203 209(d)(3) to terminate or modify this Agreement solely upon written notice to the extent Licensee if it is determined that such this action is legally necessary to meet the requirements for public use specified by federal regulations issued after the date of the applicable federal statutes or regulations license and such these requirements are not reasonably satisfied by Company. the Licensee within [***] following written notice from the NIH. 13.9 Within [***] days of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary NIH's unilateral decision to modify or terminate this Agreement, Company shallthe Licensee may, if Company disagrees consistent with such assessmentthe provisions of 37 C.F.R. §404.11, notify CHOP of such disagreement and appeal the basis for Company’s position and this Agreement shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or decision by written submission to the exercise designated NIH official. The decision of the march-in-rights by designated NIH official shall be the governmentfinal agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 12.6 13.10 Within [***] days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by the Licensee. Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expenses, due to the NIH shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with the NIH pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, the Licensee shall have the right to offer for sale and sell any existing inventory of Licensed Products for a period of [***] following the effective termination date of this Agreement, subject to the royalty obligations as set forth in Appendix C. The Licensee may not be granted additional NIH licenses if the final report and all accrued payments shall be submitted by Company. If this Agreement reporting requirement is terminated under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.4not fulfilled.

Appears in 1 contract

Samples: Patent License Agreement (Bluebird Bio, Inc.)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.1 This Agreement is effective beginning with when signed by all parties, unless the Effective Date provisions of Paragraph 14.16 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How13. 12.2 13.2 In the event that Company the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within [**] ninety (90) days after the date of notice in writing of such the default, CHOP or if not reasonably capable of remedy within such period, Licensee has not taken substantial steps to remedy the alleged default within such ninety (90) day period, the IC may terminate this Agreement by written notice.notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. ​ ‌ ​ 12.3 13.3 In the event that Company the Licensee (a) becomes insolvent, insolvent or (b) files a petition in bankruptcy, or has such a petition filed against itit and, determines to file a in either case, such petition in bankruptcyis not dismissed within sixty (60) days, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Company the Licensee shall immediately notify CHOP the IC in writing. 12.4 Company 13.4 The Licensee shall have a unilateral right to terminate this Agreement and/or or any licenses in any country without cause or territory by giving CHOP ninety the IC sixty (9060) days prior written notice to that effect. For clarity, in accordance with the foregoing, Licensee shall have a unilateral right to terminate any license in any country or territory on a patent (or patent application)-by-patent (or patent application) and country (or territory)-by-country (or territory) basis. 12.5 CHOP 13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee: (a) is not executing the Commercial Development Plan in accordance with Appendix E and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes; (b) has not achieved and is not reasonably likely to achieve the Benchmarks as may be modified under Paragraph 9.2; (c) has willfully made a material false statement of, or willfully omitted a material fact in, the license application or in any report required by this Agreement; (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping the Licensed Products or the Licensed Processes within the scope of the Licensed Fields of Use 1 and 2 reasonably accessible to the public after commercial use commences; (f) cannot reasonably satisfy unmet health and safety needs within the scope of the Licensed Fields of Use 1 and 2; (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived; or (h) has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement without the possibility of appeal. 13.6 In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports ​ ‌ ​ submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in Paragraphs 13.5(a)-13.5(h). If the Licensee fails to alleviate the IC’s reasonable concerns as to the items referenced in Paragraphs 13.5(a)-13.5(h) or fails to initiate corrective action to the IC’s reasonable satisfaction, the IC may terminate this Agreement. 13.7 When the public health and safety so require, and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, the IC shall have the right to require the Licensee to grant sublicenses to responsible applicants, on commercially reasonable terms, in any Licensed Fields of Use 1 and 2 under the Licensed Patent Rights, unless the Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. The IC shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee for a sublicense on commercially reasonable terms and conditions. 13.8 The IC reserves the right of according to 35 U.S.C. §203 209(d)(3) to terminate or modify this Agreement solely to the extent if it is determined that such this action is legally necessary to meet the requirements for public use specified by federal regulations issued after the date of the applicable federal statutes or regulations license and such these requirements are not reasonably satisfied by Company. the Licensee. 13.9 Within [**] thirty (30) days of receipt of written notice of CHOPthe IC’s belief or notification from the government that it is legally necessary unilateral decision to modify or terminate this Agreement, Company shallthe Licensee may, if Company disagrees consistent with such assessmentthe provisions of 37 C.F.R. §404.11, notify CHOP appeal the decision by written submission to the designated IC official. The decision of such disagreement the designated IC official shall be the final agency decision. The Licensee may thereafter exercise any and the basis for Company’s position and all administrative or judicial remedies that may be available. 13.10 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or submitted by the exercise of Licensee. Any royalty payments, including those incurred but not yet paid (such as the march-in-rights by full minimum annual royalty), and those related to patent expenses, due to the government. 12.6 Within [**] days of IC shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with the IC pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, a the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to the IC or provide the IC with certification of the destruction thereof. The Licensee may not be granted additional IC licenses if the final report and all accrued payments shall be submitted by Company. If this Agreement reporting requirement is terminated under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.4not fulfilled.

Appears in 1 contract

Samples: Patent License Agreement (Iovance Biotherapeutics, Inc.)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.01 This Agreement is effective beginning with as of the Effective Date and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How13. 12.2 13.02 In the event that Company Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Article 13.05, and if the default has not been remedied within [**] ninety (90) days after the date of notice in writing of such default, CHOP PHS may terminate this Agreement by written noticenotice and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Act. 12.3 13.03 In the event that Company Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third partyparry’s intention to file an involuntary petition in bankruptcy, Company Licensee shall immediately notify CHOP PHS in writing. PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of such written notice. 12.4 Company 13.04 Notwithstanding anything to the contrary in this Agreement, Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country without cause or territory by giving CHOP ninety PHS sixty (9060) days prior written notice to that effect.effect In such event. Licensee will not have any obligations whatsoever to PHS, other than for payments that should have been paid by Licensee to PHS prior to the date of the notice of termination. PHS Patent License Agreement–Exclusive CONFIDENTIAL A-046-2003 Model 980611a Page 15 of 30 FINAL Brainsway July 7, 2003 12.5 CHOP reserves 13.05 PHS shall specifically have the right of 35 U.S.C. §203 to terminate or modify this Agreement solely to the extent that such action is legally necessary to meet requirements of the applicable federal statutes or regulations and such requirements are not reasonably satisfied by Company. Within [**] days of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary to modify or terminate modify, at its option, this Agreement, Company shall, if Company disagrees with such assessment, notify CHOP PHS determines that per the submission incorporated in Appendix F of such disagreement and the basis for Company’s position and this Agreement shall the Licensee: 1) is not be terminated or modified unless and until such disagreement is resolved in accordance executing the Commercial Development Plan of Appendix F with Paragraph 13.12 or by the exercise of the march-in-rights by the government. 12.6 Within [**] days of termination or expiration of this Agreement, a final report and all accrued payments shall be submitted by Company. If this Agreement is terminated under this Article 12, sublicenses may be converted due diligence subject to direct licenses with CHOP any amendment thereto pursuant to Paragraph 4.49.02; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement; 4) has committed a material breach of a covenant or agreement contained in under this Agreement; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; 6) cannot reasonably satisfy unmet health and safety needs; 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.02 unless waived. In making this determination, PHS will take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.

Appears in 1 contract

Samples: Patent License Agreement (Brainsway Ltd.)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 12.01 This Agreement AGREEMENT, when signed by all parties, is effective beginning with as of September 11, 1997, which is the Effective Date date upon which Licensee obtained the tangible material(s) identified in Appendix A, and shall extend to June 11, 2002, which is the date of expiration of the last to expire of the Patent Rights LICENSED PATENT RIGHTS, or such earlier date if the LICENSED PATENT RIGHTS are held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction in the LICENSED TERRITORY prior to June 11, 2002, unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How. 12.2 12.02 In the event that Company LICENSEE is in default in the performance of any material obligations under this AgreementAGREEMENT, including but not limited to the obligations listed in Article 12.05, and if the default has not been remedied within [**] ninety (90) days after the date of notice in writing of such default, CHOP PHS Patent license Agreement -- Nonexclusive CONFIDENTIAL L-176-99/0 Mode l980611 Page 6 FINAL AltaRexCorp. September 9, 1999 7 PHS may terminate this Agreement AGREEMENT by written noticenotice and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Act. 12.3 12.03 In the event that Company LICENSEE becomes insolvent, files a Chapter 7 petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, it or receives notice of a third party’s 's intention to file an involuntary Chapter 7 petition in bankruptcybankruptcy and such bankruptcy proceeding is not dismissed within ninety (90) days of filing, Company LICENSEE shall immediately notify CHOP PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon receipt of LICENSEE'S written notice. 12.4 Company 12.04 LICENSEE shall have a unilateral right to terminate this Agreement and/or any licenses AGREEMENT in any country without cause or territory by giving CHOP ninety PHS sixty (9060) days prior written notice to that effect. 12.5 CHOP reserves 12.05 PHS shall specifically have the right of 35 U.S.C. §203 to terminate or modify modify, at its option, this Agreement solely AGREEMENT, if PHS determines that the LICENSEE: 1) is not executing the COMMERCIAL DEVELOPMENT PLAN submitted with its request for a license and the LICENSEE cannot otherwise demonstrate to PHS'S satisfaction that the LICENSEE has taken, or can be expected to take within a reasonable time, effective steps to achieve PRACTICAL APPLICATION of the LICENSED PRODUCTS or LICENSED Processes; 2) has not achieved the BENCHMARKS as may be modified under Paragraph 8.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by the license AGREEMENT; 4) has committed a material breach of a covenant or agreement contained in the license; 5) is not keeping LICENSED PRODUCTS or LICENSED PROCESSES reasonably available to the extent that such action is legally necessary to meet requirements of the applicable federal statutes or regulations and such requirements are public after commercial use commences; 6) cannot reasonably satisfied by Company. Within [**] days justify a failure to comply with the domestic production requirement of receipt of written notice of CHOP’s belief or notification from the government that it is legally necessary to modify or terminate this Agreement, Company shall, if Company disagrees with such assessment, notify CHOP of such disagreement and the basis for Company’s position and this Agreement shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or by the exercise of the march-in-rights by the government. 12.6 Within [**] days of termination or expiration of this Agreement, a final report and all accrued payments shall be submitted by Company. If this Agreement is terminated under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.4.5.02

Appears in 1 contract

Samples: Patent License Agreement (Altarex Corp)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.1 This Agreement is effective beginning with when signed by all parties, unless the Effective Date provisions of Paragraph 14.16 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How13. 12.2 13.2 In the event that Company the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within [**] ninety (90) days after the date of notice in writing of such the default, CHOP the NIH may terminate this Agreement by written noticenotice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. 12.3 13.3 In the event that Company becomes insolventthe Licensee, files a petition in bankruptcy, or has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Company the Licensee shall immediately notify CHOP the NIH in writing. Furthermore, to the extent allowed under applicable law, the NIH shall have the right to terminate this Agreement immediately upon the Licensee’s receipt of written notice; provided, however, that with respect to any petition filed against the Licensee, the NIH shall not have the right to terminate this Agreement if the Licensee A-563-2014 NIH Patent License Agreement – Exclusive Page 15 [Kite Pharma, Inc.] [December 18, 2014] is able to resolve or obtain the dismissal of such petition within [10*…***…] following the date of such notice. 12.4 Company 13.4 The Licensee shall have a unilateral right to terminate this Agreement and/or or any licenses in any Licensed Field of Use in any country without cause or territory by giving CHOP ninety the NIH sixty (9060) days prior written notice to that effect. 12.5 CHOP 13.5 The NIH shall specifically have the right to terminate or modify, at its option, this Agreement by written notice to the Licensee, if the NIH determines in good faith that the Licensee: (a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; (b) has not achieved the Benchmarks as may be modified under Paragraph 9.2; (c) has willfully made a false statement of, or willfully omitted a material fact in the license application or in any report required by this Agreement; (d) has committed a material breach of a covenant or Agreement contained in this Agreement that has not been remedied within the ninety (90) days period set forth in Paragraph 13.2 above; (e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; or (f) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 13.6 In making the determination referenced in Paragraph 13.5, the NIH shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to remedy the items referenced in Paragraphs 13.5(a)-13.5(g). If the Licensee fails to alleviate the NIH’s concerns as to the items referenced in Paragraphs 13.5(a)-13.5(g) within ninety (90) days following written notice from the NIH or otherwise fails to initiate corrective action to the NIH’s satisfaction, the NIH may terminate this Agreement upon written notice to the Licensee. 13.7 When the public health and safety so require and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, the NIH shall have the right to require the Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any of the Licensed Field of Use under the Licensed Patent Rights, unless the Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. The NIH shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee. 10 ** * ***Confidential Treatment Requested A-563-2014 NIH Patent License Agreement – Exclusive Page 16 [Kite Pharma, Inc.] [December 18, 2014] 13.8 The NIH reserves the right of according to 35 U.S.C. §203 209(d)(3) to terminate or modify this Agreement solely upon written notice to the extent Licensee if it is determined that such this action is legally necessary to meet the requirements for public use specified by federal regulations issued after the date of the applicable federal statutes or regulations license and such these requirements are not reasonably satisfied by Company. the Licensee within ninety (90) days following written notice from the NIH. 13.9 Within [**] thirty (30) days of after receipt of written notice of CHOPthe NIH’s belief or notification from the government that it is legally necessary unilateral decision to modify or terminate this Agreement, Company shallthe Licensee may, if Company disagrees consistent with such assessmentthe provisions of 37 C.F.R. §404.11, notify CHOP appeal the decision by written submission to the designated NIH official. The decision of such disagreement the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any and the basis for Company’s position and all administrative or judicial remedies that may be available. 13.10 Within [11*…***…] after expiration or termination of this Agreement under this Article 13, a final report shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or submitted by the exercise of Licensee. Any royalty payments, including those incurred but not yet paid (such as the march-in-rights by full minimum annual royalty), and those related to patent expense, due to the government. 12.6 Within [**] days of NIH shall become immediately due and payable upon termination or expiration expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with the NIH pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, a the Licensee shall have the right to offer for sale and sell any existing inventory of Licensed Products for […***…] following the effective termination date of this Agreement, subject to the royalty obligations as set forth in Appendix C. After this […***…] period, the Licensee shall return all remaining Licensed Products or other materials included within the Licensed Patent Rights to the NIH or provide the NIH with certification of the destruction thereof. The Licensee may not be granted additional NIH licenses if the final report and all accrued payments shall be submitted by Company. If this Agreement reporting requirement is terminated under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.4not fulfilled.

Appears in 1 contract

Samples: Patent License Agreement (Kite Pharma, Inc.)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 13.1 This Agreement is effective beginning with when signed by all parties, unless the Effective Date provisions of Paragraph 14.16 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 12. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product, Company’s rights under Article 3 of this Agreement shall cease, effective immediately, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-How13. 12.2 13.2 In the event that Company the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, IC shall give written notice to the Licensee and if a ninety (90) day period to remedy the default. If the Licensee fails to take substantive steps to remedy the default has not been remedied to the IC’s satisfaction within [**] days after such ninety (90) day period, the date of notice in writing of such default, CHOP IC may terminate this Agreement by written noticenotice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. 12.3 13.3 In the event that Company the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s 's intention to file an involuntary petition in bankruptcy, Company the Licensee shall immediately notify CHOP the IC in writing. 12.4 Company 13.4 The Licensee shall have a unilateral right to terminate this Agreement and/or or any licenses in any country without cause or territory by giving CHOP ninety the IC sixty (9060) days prior written notice to that effect. 12.5 CHOP reserves 13.5 The IC shall specifically have the right of 35 U.S.C. §203 to terminate or modify modify, at its option, this Agreement, if the IC determines that the Licensee: (a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes; (b) has not achieved the Benchmarks as may be modified under Paragraph 9.2; (c) has willfully made a false statement of, or willfully omitted a material fact in the license application or in any report required by this Agreement; NIH Patent License Agreement—Exclusive (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping the Licensed Products or the Licensed Processes reasonably available to the public after commercial use commences; (f) cannot reasonably satisfy unmet health and safety needs; or (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 13.6 In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement solely under Paragraph 13.5, the IC shall give written notice to the extent that such Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action is legally necessary to meet requirements of the applicable federal statutes or regulations and such requirements are not reasonably satisfied by Company. Within [**] days of receipt of written notice of CHOPIC’s belief or notification from satisfaction, the government that it is legally necessary to modify or IC may terminate this Agreement. 13.7 When the public health and safety so require and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, Company shallthe IC shall have the right to require the Licensee to grant sublicenses to responsible applicants, if Company disagrees with such assessmenton commercially reasonable terms, notify CHOP in any Licensed Fields of such disagreement and Use under the basis for Company’s position and this Agreement shall not be terminated or modified Licensed Patent Rights, unless and until such disagreement is resolved in accordance with Paragraph 13.12 or by the exercise Licensee can reasonably demonstrate that the granting of the march-in-rights by sublicense would not materially increase the government. 12.6 Within [**] days availability to the public of termination or expiration the subject matter of this Agreement, a final report and all accrued payments shall be submitted by Company. If this Agreement is terminated under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.4.the

Appears in 1 contract

Samples: Patent License Agreement (Scopus Biopharma Inc.)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 12.1 14.01 This Agreement AGREEMENT is effective beginning with when signed by the Effective Date parties upon the EFFECTIVE DATE and shall extend to the expiration of the last to expire of the Patent Rights LICENSED PATENT RIGHTS unless sooner terminated as provided in this Article 1214. Upon termination of this Agreement pursuant to this Article 12 as to a Licensed Product prior to expiration of Company’s royalty obligations with respect to such Licensed Product[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, Company’s rights under Article 3 of this Agreement shall ceaseMARKED BY BRACKETS, effective immediatelyHAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, with respect to such Licensed Product. After Company’s royalty obligations as to a Licensed Product have expired in a country, Company shall have a perpetual, full and unrestricted right to make, use, offer for sale, sell and import such Licensed Product in such country under the Patent Rights, Gene-Therapy Know-How and Know-How. Following expiration of this Agreement in its entirety, Company’s rights under Article 3 of this Agreement shall convert to a fully paid-up, non-royalty bearing, perpetual, unrestricted right to use the Patent Rights, Gene-Therapy Know-How and Know-HowAS AMENDED. 12.2 14.02 In the event that Company LICENSEE is in default in the performance of any material obligations under this AgreementAGREEMENT, including but not limited to the obligations listed in Paragraph 14.05, and if the default has not been remedied within [**] days after the date of notice in writing of such default, or if such default is not capable of remedy within such [*] day period, then if LICENSEE has not commenced good faith efforts to cure such default, CHOP may terminate this Agreement AGREEMENT by written notice, and provided that if such breach is specific as to a given country or countries with respect to a given LICENSED PRODUCT, such termination shall not be as to whole AGREEMENT, but only as to such LICENSED RIGHTS as granted hereunder to LICENSEE with respect to such country or countries and such LICENSED PRODUCT. 12.3 14.03 In the event that Company LICENSEE becomes insolventsubject to a BANKRUPTCY EVENT, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Company LICENSEE shall immediately notify CHOP in writing. 12.4 Company 14.04 LICENSEE shall have a unilateral right to terminate this Agreement AGREEMENT and/or any licenses in any country without cause by giving CHOP ninety (90) [*] days prior written notice to that effect. Such termination is final and CHOP, at its sole discretion, shall be free thereafter to license LICENSED PATENT RIGHTS and LICENSED TECHNOLOGIES to other interested parties in such country. 12.5 14.05 CHOP reserves shall specifically have the right of 35 U.S.C. §203 to terminate or modify modify, at its option, this Agreement solely AGREEMENT, if CHOP determines that the LICENSEE: 1) has not achieved the performance BENCHMARKS listed in APPENDIX D and the LICENSEE cannot otherwise demonstrate to the extent that such action is legally necessary to meet requirements of the applicable federal statutes or regulations and such requirements are not reasonably satisfied by Company. Within CHOP'S reasonable satisfaction within [**] days of receipt failing to achieve the performance BENCHMARKS that the LICENSEE has taken, or can be expected to take within a reasonable time, effective steps to achieve the performance BENCHMARKS and PRACTICAL APPLICATION of written notice the LICENSED PRODUCTS; 2) has become subject to a BANKRUPTCY EVENT; 3) has not paid any royalty or other payment due CHOP; [*] 5) has committed a material breach of CHOP’s belief a covenant or notification from agreement contained in the government that it is legally necessary to modify or terminate AGREEMENT; [*] In making this Agreementdetermination, Company shall, if Company disagrees with such assessment, notify CHOP will take into account the normal course of such disagreement commercial development programs conducted with sound and reasonable business practices and judgment and the basis for Company’s position and this Agreement shall not be terminated or modified unless and until such disagreement is resolved in accordance with Paragraph 13.12 or by the exercise of the march-in-rights by the government. 12.6 Within [**] days of termination or expiration of this Agreement, a final report and all accrued payments shall be annual reports submitted by Company. If this Agreement is terminated LICENSEE under this Article 12, sublicenses may be converted to direct licenses with CHOP pursuant to Paragraph 4.49.

Appears in 1 contract

Samples: Factor Ix Patent and Know How Exclusive License Agreement (Avigen Inc \De)

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