TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 This AGREEMENT is effective when signed by all Parties (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as provided in this Article 13. 13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page. 13.03 Except as otherwise provided in Section 13.05, in the event that LICENSEE is in default in performance of any material obligation under this AGREEMENT, and if the default has not been remedied within ninety (90) days after the date of notice in writing of such default, PHS may terminate this AGREEMENT by written notice and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Act. 13.04 LICENSEE shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT. 13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS shall specifically have the right to terminate or modify, at its option, this 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
Appears in 1 contract
Sources: Patent License Agreement (Millennium Pharmaceuticals Inc)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties parties, unless the provisions of Paragraph 14.16 are not fulfilled, and shall extend, on a Licensed Product-by-Licensed Product (the "effective date"or Licensed Process-by-Licensed Process) and shall extend country-by-country basis, to the expiration of the last to expire of the LICENSED PATENT RIGHTS Licensed Patent Rights that claims such Licensed Product (or Licensed Process) in such country unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC reasonably determines that the LICENSEE: 1Licensee:
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license license, as may be amended pursuant to Paragraph 9.2, and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE 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 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; 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.
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 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 When the public health and safety so require, and after written notice to the Licensee providing the Licensee a [***] opportunity to respond, the IC 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 IC shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee.
13.8 The IC reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.9 Within [***] of receipt of written notice of the IC’s [***] to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated IC official or designee. The decision of the designated IC official or designee shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.
13.10 Within [***] 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 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, 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 IC licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent License Agreement (Dynamics Special Purpose Corp.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement shall not take effect unless and until:
(a) Licensee has paid to the IC a noncreditable, nonrefundable license issue royalty in the amount and as set as set forth in Appendix B;
(b) Licensee has paid the first royalty installment for Past-patent Costs reimbursement, under paragraph 6.9(a); and
(c) the Agreement has been signed by the authorized representatives of the parties, in accordance to the provisions of Paragraph 14.16. Upon fulfillment of all conditions under this paragraph 13.1(a-c), this Agreement is effective when signed by all Parties (on the "effective date") Effective Date.
13.2 This Agreement shall take effect on 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 13.) either:
13.02 The terms (a) Thirty-six (36) months from the Effective Date, if not extended in accordance with 13.2 (b); or
(b) if Licensee has (i) paid to the IC the License Extension Royalty as specified in Appendix C (IV), and conditions (ii) provided IC written evidence of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration commercially reasonable progress toward Licensee-sponsored clinical studies of a Licensed Product and adherence with the terms Commercial Development Plan, (such evidence may include, but is not limited to, completed experiments showing non-clinical pharmacology or toxicology data, and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60any completed regulatory filings) days from on the date of printing indicated at the bottom last to expire of each pagethe Licensed Patent Rights.
13.03 Except as otherwise provided in Section 13.05, in 13.3 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.4 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.5 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States CONFIDENTIALNIH Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.License Agreement--ExclusiveModel 10-2015 Page 15 of 33 [Final] [Connectyx] [January 2021]
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.6 The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEE: 1Licensee:
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE 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 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 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.
13.7 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 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.
13.8 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 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
Appears in 1 contract
Sources: Patent License Agreement (Curative Biotechnology Inc)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties parties, (the "effective date") “Effective Date”), and shall extend to the expiration of the last to expire of (a) the LICENSED PATENT RIGHTS 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 under Article 6 or 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or any licenses Agreement in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEE: 1Licensee:
(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 executing keeping Licensed Products or Licensed Processes reasonably available to the COMMERCIAL DEVELOPMENT PLAN 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 with its request 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 according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the action is necessary to meet the requirements for a public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the LICENSEE canLicensee.
13.8 Within [***] ([***]) days of receipt of written notice of the IC’s unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 CFR §404.11, appeal the decision by written submission to the designated the IC official. The decision of the designated IC official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.
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 demonstrate specifically provided for under this Agreement, upon termination or expiration of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS's satisfaction that the LICENSEE has taken, IC or can provide the IC with written certification of the destruction thereof. The Licensee may not be expected to take within a reasonable time, effective steps togranted additional the IC licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent License Agreement (LogicBio Therapeutics, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or any licenses Agreement in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEE: 1Licensee:
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE 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
(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, 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 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 according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.8 Within thirty (30) days of receipt of written notice of the IC’s unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated the IC official. The decision of the designated IC official shall be the final agency decision. The Licensee may thereafter exercise any 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 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. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, 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 IC licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in . In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the NIH may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE . In the event that 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, the Licensee shall immediately notify the NIH in writing. The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the NIH sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS The NIH shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the NIH determines that the LICENSEELicensee: 1) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the NIH’s satisfaction that the LICENSEE 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; has not achieved the Benchmarks as may be modified under Paragraph 9.2; 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; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping the Licensed Products or the Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 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. 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. The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee. Within thirty (30) days of receipt of written notice of the NIH's unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated NIH official. The decision of the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be accessible. Within ninety (90) 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 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 reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 12.01 This AGREEMENT is effective AGREEMENT, when signed by all Parties (parties, is effective 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 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 1312.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 12.02 In the event that LICENSEE is in default in the performance of any material obligation obligations under this AGREEMENT, 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, 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 by written notice and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Act.
13.04 12.03 In the event that LICENSEE becomes insolvent, files a Chapter 7 petition in bankruptcy, has such a petition filed against it or receives notice of a third party's intention to file an involuntary Chapter 7 petition in bankruptcy and such bankruptcy proceeding is not dismissed within ninety (90) days of filing, LICENSEE shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon receipt of LICENSEE'S written notice.
12.04 LICENSEE shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or any licenses AGREEMENT in any country or territory by giving PHS sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), 12.05 PHS shall specifically have the right to terminate or modify, at its option, this 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 'S satisfaction that the LICENSEE has taken, or can be expected to take within a reasonable time, effective steps toto 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 public after commercial use commences; 6) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.02
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 This AGREEMENT is effective when signed by all Parties (the "effective date") parties and shall extend to the expiration of the last to expire of the LICENSED PATENT RIGHTS unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in In the event that LICENSEE is in default in the performance of any material obligation 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, PHS may terminate this AGREEMENT by written notice and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Act.
13.03 In the event that 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, LICENSEE shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this AGREEMENT immediately upon LICENSEE’S receipt of written notice.
13.04 LICENSEE shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B AGREEMENT and/or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS shall specifically have the right to terminate or modify, at its option, this 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 ’s satisfaction that the LICENSEE has taken, or can be expected to take within a reasonable time, effective steps toto achieve PRACTICAL APPLICATION of the LICENSED PRODUCTS or LICENSED PROCESSES; 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 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 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
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or any licenses Agreement in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEE: 1Licensee:
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE 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;
(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.
(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.
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 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 according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.8 Within thirty (30) days of receipt of written notice of the IC’s unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 CFR §404.11, appeal the decision by written submission to the designated the IC official. The decision of the designated IC official shall be the final agency decision. The Licensee may thereafter exercise any 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 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, 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 reporting requirement is not fulfilled.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEE: 1Licensee:
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE 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
(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, 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 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 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 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 IC shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee.
13.8 The IC reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.9 Within thirty (30) days of receipt of written notice of the IC's unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated the IC official, or designee. The decision of the designated IC official, or designee, shall be the final agency decision. The Licensee may thereafter exercise any 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 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, 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 the IC licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (parties, unless the "effective date") provisions of Paragraph 14.14 are not fulfilled, and shall extend on a country-by-country basis to the later of (a) twenty (20) years from the First Commercial Sale where no Licensed Patent Rights exist or have ceased to exist, or (b) to the expiration of the last to expire of the LICENSED PATENT RIGHTS Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee (or its Affiliate(s)) is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) calendar days after the date of notice in writing of such the default, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or any licenses Agreement completely or in any country or territory of the Licensed Territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the unilateral right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEE: 1Licensee (or its Affiliate(s)):
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE 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 9.1;
(c) has willfully made a false statement of, or willfully omitted, a material fact in the license application, negotiation of this Agreement, or in any report required by this Agreement; 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;
(g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived;
(h) has not provided timely annual progress or semi-annual royalty reports to IC under Article 9; or
(i) has not made timely royalty payments to IC under Article 6.
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 9.3. 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 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 according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.8 Within thirty (30) calendar days of receipt of written notice of the IC’s unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 CFR §404.11, appeal the decision by written submission to the designated the IC official. The decision of the designated IC official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.
13.9 Within ninety (90) calendar 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.
13.10 Unless otherwise specifically provided for under this Agreement, within thirty (30) calendar days of termination, cancellation or expiration of this Agreement, the Licensee shall return all Materials, 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 HHS licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent and Biological Materials License Agreement (GeoVax Labs, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in . In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE . In the event that 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, the Licensee shall immediately notify the IC in writing. The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEELicensee: 1) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE 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; has not achieved the Benchmarks as may be modified under Paragraph 9.2; 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; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping the Licensed Products or the Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 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 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.
Appears in 1 contract
Sources: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the NIH may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, or receives notice of a third party's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any Licensed Fields of Use in any country or territory by giving PHS sixty (60) days the NIH [***] written notice to that effect. Upon any such termination by LICENSEEA-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, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENTAS AMENDED.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The NIH shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement by written notice to the Licensee, if PHS the NIH reasonably determines that the LICENSEE: 1Licensee:
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the NIH’s satisfaction that the LICENSEE 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 according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement upon written notice to the Licensee if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee within [***] following written notice from the NIH.
13.9 Within [***] of receipt of written notice of the NIH's unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated NIH official. The decision of the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.
13.10 Within [***] 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 reporting requirement is not fulfilled.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective as of 1 August 2017 when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEELicensee: 1NIH Patent License Agreement--Exclusive
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE 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 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 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 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 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 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 IC shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee.
13.8 The IC reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.9 Within thirty (30) days of receipt of written notice of the IC’s unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated IC official or designee. The decision of the designated IC official or designee shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be accessible. NIH Patent License Agreement--Exclusive
13.10 Within ninety (90) 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 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, 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 reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent License Agreement (Atlantic Coastal Acquisition Corp. II)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 a Valid Claim within the LICENSED PATENT RIGHTS Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the right to terminate or modifythis Agreement pursuant to Paragraph 13.6, at its option, this AGREEMENTsuch termination to be deemed effective upon the earliest of: (i)expiration of the time period by which Licensee can submit a formal written appeal, if PHS such period expires without submission by Licensee of such appeal, (ii) upon final agency decision in response to the formal written appeal in accordance with Paragraph 13.9, or (iii) upon Licensee’s written notification of its acceptance of the termination of this Agreement, if the IC reasonably determines that the LICENSEE: 1Licensee:
(a) is not executing using commercially reasonable efforts to execute the COMMERCIAL DEVELOPMENT PLAN submitted with its request for a license Commercial Development Plan attached as Appendix E of this Agreement) and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s reasonable satisfaction that the LICENSEE 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; A-440-2021 NIH Patent License Agreement--Exclusive Model 10-2015 Page 19 of 28 [Draft v1] [Sana] [12/16/2021]
(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 [***] day 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; 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.
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(h). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 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 [***] day opportunity to respond, the IC 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 alleviate concerns of public health and safety and materially increase the availability to the public of the subject matter of the Licensed Patent Rights in the Licensed Fields of Use. The IC shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee.
13.8 The IC reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement upon written notice to the Licensee if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.9 Within [***] days of receipt of written notice of the IC’s unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated IC official or designee. The decision of the designated IC official or designee shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be accessible. A-440-2021 NIH Patent License Agreement--Exclusive Model 10-2015 Page 20 of 28 [Draft v1] [Sana] [12/16/2021]
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 IC shall become due and payable within [***] days of 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 early termination (prior to expiration) of this Agreement, the Licensee shall destroy all Licensed Products or other materials included within the Licensed Patent Rights and, upon written request, provide the IC with certification of the destruction thereof. The Licensee may not be granted additional IC licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent License Agreement (Sana Biotechnology, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 This AGREEMENT 14.01 The term of this Agreement is effective when signed by all Parties (as of the "effective date") Effective Date and shall extend to the expiration of the last to expire of claim contained in the LICENSED PATENT RIGHTS Licensed Patent Rights (the “Term”) unless sooner terminated as provided in this Article 1314.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 14.02 In the event that LICENSEE OXIQUANT is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, and if the default has not been remedied within ninety sixty (9060) days after the date of notice in writing from OHSU to OXIQUANT of such default, PHS OHSU may terminate this AGREEMENT the Term by written notice and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Actto OXIQUANT.
13.04 LICENSEE shall have a unilateral right to terminate this AGREEMENT14.03 OXIQUANT may, any of the LICENSED FIELDS OF USE in Appendix B and/or any licenses in any country or territory by giving PHS upon sixty (60) days written notice to that effect. Upon OHSU, terminate this Agreement by doing all of the following:
a) Ceasing to make, have made, use, import, sell and offer for sale any such termination by LICENSEELicensed Products and/or use of Licensed Processes;
b) Terminating all sublicenses, LICENSEE and PHS shall each havecausing all sublicensees to cease making, in the relevant country or territoryhaving made, the right using, importing, selling and offering for sale any Licensed Products and/or use of Licensed Processes; and
c) Paying all monies owed to practice the subject matter covered by the LICENSED PATENT RIGHTS determined OHSU under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENTAgreement.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 14.04 OHSU shall specifically have the right right, but not the obligation, to terminate this Agreement if OHSU determines that: 1) OXIQUANT is more than sixty (60) days late in paying to OHSU any consideration due under this Agreement and OXIQUANT does not immediately pay OHSU in full upon OHSU’s written demand, 2) OXIQUANT experiences a Trigger Event, or modify3) 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 of expiration or termination of this Agreement under this Article 14, a final report shall be submitted by OXIQUANT. 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 14, sublicensees may elect to convert their sublicenses to direct licenses with OHSU subject to Paragraph 4.03.
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 optionown 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 AGREEMENTAgreement 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, if PHS determines that the LICENSEE: 1) is not executing the COMMERCIAL DEVELOPMENT PLAN submitted with its request for a license 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 the LICENSEE cannot otherwise demonstrate 17.01-17.12 of this Agreement shall survive termination of this Agreement. OXIQUANT’s obligation to PHS's satisfaction that the LICENSEE has taken, or can be expected to take within a reasonable time, effective steps topay all monies owed accruing under this Agreement shall survive termination of this Agreement.
Appears in 1 contract
Sources: Exclusive License Agreement (Adherex Technologies Inc)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the NIH may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, or receives notice of a third party's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any Licensed Fields of Use in any country or territory by giving PHS sixty (60) days the NIH [***] written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The NIH shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement by written notice to the Licensee, if PHS the NIH reasonably determines that the LICENSEE: 1Licensee:
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the NIH’s satisfaction that the LICENSEE 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; 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.
(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.
13.8 The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement upon written notice to the Licensee if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee within [***] following written notice from the NIH.
13.9 Within [***] of receipt of written notice of the NIH's unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated NIH official. The decision of the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.
13.10 Within [***] 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 reporting requirement is not fulfilled. 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.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the NIH may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, or receives notice of a third party's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any Licensed Fields of Use in any country or territory by giving PHS sixty (60) days the NIH [***] written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The NIH shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement by written notice to the Licensee, if PHS the NIH reasonably determines that the LICENSEE: 1Licensee:
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the NIH’s satisfaction that the LICENSEE 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.
13.8 The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement upon written notice to the Licensee if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee within [***] following written notice from the NIH.
13.9 Within [***] of receipt of written notice of the NIH's unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated NIH official. The decision of the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.
13.10 Within [***] 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 reporting requirement is not fulfilled.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 12.01 This AGREEMENT is effective when signed by all Parties (the "effective date") parties and shall extend to the expiration of the last to expire of the LICENSED PATENT RIGHTS unless sooner terminated as provided in this Article 1312.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 12.02 In the event that LICENSEE is in default in the performance of any material obligation obligations under this AGREEMENT, 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, PHS PDM may terminate this AGREEMENT by written notice and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Actnotice.
13.04 12.03 In the event that 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, LICENSEE shall immediately notify PDM in writing.
12.04 LICENSEE shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B AGREEMENT and/or any licenses in any country or territory by giving PHS PDM sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 12.05 PDM shall specifically have the right to terminate or modify, at its option, this AGREEMENT, if PHS PDM 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 PHSPDM's satisfaction that the LICENSEE has taken, or can be expected to take within a reasonable time, effective steps toto 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
Appears in 1 contract
Sources: Patent License Agreement (Utek Corp)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT is Agreement shall become effective when signed by all Parties (as of the "effective date") Effective Date unless the provisions of Paragraph 14.16 are not fulfilled and shall extend expire twenty-four (24) months from its Effective Date. Within sixty (60) days of the termination or expiration of this Agreement, unless an IC Exclusive or Non-exclusive Commercial Patent License has been executed for the Licensed Patent Rights in the Licensed Field(s) of Use, as stipulated in Paragraph 3.3 of this Agreement, the Licensee shall return all Materials and Licensed Products to the expiration IC or provide the IC with written certification of the last to expire of the LICENSED PATENT RIGHTS unless sooner terminated as provided in this Article 13.
13.02 their destruction. The terms and conditions of this AGREEMENT Licensee further agrees that it shall be considered by PHS responsible for the destruction of any remaining Materials and Licensed Products from the Third Party Contractor(s) to be withdrawn from LICENSEE's consideration the Licensee, and the terms Licensee shall obtain written certification from the Third Party Contractor(s) that any remaining Materials or Licensed Products in their possession have been destroyed and conditions to provide IC with a copy of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed said written notification within sixty (60) days from of the date termination or expiration of printing indicated at the bottom of each pagethis Agreement.
13.03 Except as otherwise provided in Section 13.05, in 13.2 The IC reserves the event right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it determines that LICENSEE this action is in default in performance of any material obligation under this AGREEMENT, and if necessary to meet the default has not been remedied within ninety (90) days requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.3 The IC shall specifically have the right to terminate or modify this Agreement, at its sole option, if the IC determines that the Licensee:
(a) has not adhered to the Commercial Evaluation Plan in Appendix E, as may be amended by mutual agreement of the parties;
(b) has not performed or has not exercised reasonable commercial efforts towards performance of the Benchmarks by the requisite deadlines specified in Appendix D, as may be modified under Paragraph 10.3;
(c) has willfully made a false statement 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; or
(e) cannot reasonably satisfy unmet health and safety needs.
13.4 Within thirty (30) days of receipt of written notice in writing of such default, PHS may the IC’s unilateral decision to modify or terminate this AGREEMENT Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written notice and pursue outstanding amounts owed through procedures provided by submission to the Federal Debt Collection Actdesignated IC official or designee. The decision of the designated IC official or designee shall be the final agency decision. The Licensee may thereafter exercise all administrative or judicial remedies that may be accessible.
13.04 LICENSEE 13.5 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such NIH Patent License Agreement--Exclusive Model 10-2015 Page 11 of 24 [Draft2] [Connectyx] [2020 September]
13.6 Within thirty (30) days of expiration or termination by LICENSEEof this Agreement under this Article 13, LICENSEE and PHS a final written report shall each have, in the relevant country or territory, the right to practice the subject matter covered be submitted by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others Licensee in all fields, countries or territories not covered by this AGREEMENTaccordance with Paragraph 9.
13.05 Solely 1. The Licensee may not be granted additional IC licenses if this final reporting requirement is not fulfilled. Any royalty payments, including those incurred but not yet paid, and those related to patent expenses, due to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS IC shall specifically have the right to terminate become immediately due and payable upon termination or modify, at its option, this 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 toexpiration.
Appears in 1 contract
Sources: Patent License Agreement (Curative Biotechnology Inc)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, including but not limited to the obligations listed in Paragraph 13.5, A-429-2017 NIH Patent License Agreement-Exclusive [***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. and if the default has not been remedied within ninety (90) days after the date of notice in writing of such the default, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEE: 1Licensee:
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE 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 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 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 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. A-429-2017 NIH Patent License Agreement-Exclusive [***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
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 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
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (parties, unless the "effective date") provisions of Paragraph 14.16 are not fulfilled, and shall extend to extend, on a Licensed Product-by-Licensed Product, Licensed Process-by-Licensed Process and country-by-country basis, until the expiration of the last to last-to- expire Valid Claim of the LICENSED PATENT RIGHTS Jointly Owned Licensed Patent Rights in such country in the Licensed Territory unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the right to terminate or modify, at its option, modify this AGREEMENTAgreement, if PHS the IC determines that the LICENSEE: 1Licensee (and its Affiliates and Sublicensees):
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license license, and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s reasonable satisfaction that the LICENSEE Licensee (and/or its Affiliate and/or its Sublicensee) 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 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; 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.
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 13.5(a)-13.5(h). If the Licensee fails to reasonably alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to develop a corrective action plan and initiate such corrective action plan to the IC’s reasonable satisfaction, the IC may terminate this Agreement.
13.7 Subject to Paragraph 13.9 below, the IC reserves the right according to 35 U.S.C. §209(d)(3)to terminate or modify this Agreement if it is determined that the action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.8 Within thirty (30) days after receipt of written notice of the IC’s unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated IC official or its designee. The decision of the designated IC official or its designee shall be the final agency decision. The Licensee may thereafter exercise any 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 be submitted by the Licensee. Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), that are 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. The Licensee may not be granted additional IC licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent License Agreement (Lixte Biotechnology Holdings, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 This AGREEMENT is 13.1 On the Amendment Signing Date, this Amended and Restated Agreement shall be, and is, effective when signed by all Parties (as of the "effective date") Amendment Effective Date and shall extend to on a country-by-country basis until the expiration of the last to expire of the LICENSED PATENT RIGHTS Licensed Patent Rights unless sooner terminated as provided in this Article 13, unless the provisions of Paragraph 14.14 are not fulfilled.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAmended and Restated 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, PHS the NIAID may terminate this AGREEMENT Amended and Restated Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the NIAID in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or any licenses Amended and Restated Agreement in any country or territory by giving PHS the NIAID sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The NIAID shall specifically have the right to terminate or modify, at its option, this AGREEMENTAmended and Restated Agreement, if PHS the NIAID determines that the LICENSEE: 1Licensee:
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the NIAID’s satisfaction that the LICENSEE 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 Amended and Restated Agreement;
(d) has committed a material breach of a covenant or agreement contained in this Amended and Restated Agreement; CONFIDENTIAL [***] Based on Patent License Non-Exclusive Sublicensable Agreement Model EXECUTION VERSION
(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;
(g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived; or
(h) has been finally found by a court of competent jurisdiction to have violated the Federal antitrust laws, without the possibility of appeal, in connection with its performance under this Amended and Restated Agreement.
13.6 In making the determination referenced in Paragraph 13.5, the NIAID 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 Amended and Restated Agreement under Paragraph 13.5, the NIAID shall give written notice to the Licensee providing the Licensee specific notice of, and a [***] day opportunity to respond to, the NIAID’s concerns as to the items referenced in Paragraphs 13.5(a)-13.5(h). If the Licensee fails to alleviate the NIAID’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to the NIAID’s satisfaction, the NIAID may terminate this Amended and Restated Agreement.
13.7 The NIAID reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Amended and Restated Agreement if it is determined that the action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.8 Within [***] days of receipt of written notice of the NIAID’s unilateral decision to modify or terminate this Amended and Restated Agreement, the Licensee may, consistent with the provisions of 37 CFR §404.11, appeal the decision by written submission to the designated the NIH official. The decision of the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.
13.9 Within [***] days of expiration or termination of this Amended and Restated 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 NIAID shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Amended and Restated Agreement, upon termination or expiration of this Amended and Restated Agreement, the Licensee shall return all Licensed Products or other 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 the NIAID licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent License Non Exclusive Sublicensable Agreement (BioNTech SE)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS 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 NIH may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that the Licensee (i) becomes insolvent, (ii) files a petition in bankruptcy, or has such a petition filed against it and, in either case, such petition is not dismissed within sixty (60) days, the Licensee shall immediately notify the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the NIH sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The NIH shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the NIH determines that the LICENSEELicensee: 1CONFIDENTIAL NIH Patent License Agreement--Exclusive Model 10-2005 (updated 8-2012) Page 13 of 28 Final Lion Biotechnologies, Inc. February 2, 2015 03424-0001 266291.2
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the NIH’s satisfaction that the LICENSEE 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 reasonably accessible 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 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 reasonable concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the NIH’s reasonable 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 commercially 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 for a sublicense on commercially reasonable terms and conditions.
13.8 The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee. NIH Patent License Agreement--Exclusive Model 10-2005 (updated 8-2012) Page 14 of 28 Final Lion Biotechnologies, Inc. February 2, 2015 03424-0001 266291.2
13.9 Within thirty (30) days of receipt of written notice of the NIH's unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated NIH official. The decision of the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any 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 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 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 reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS 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 NIH may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that the Licensee (i) becomes insolvent, (ii) files a petition in bankruptcy, or has such a petition filed against it and, in either case, such petition is not dismissed within sixty (60) days, the Licensee shall immediately notify the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the NIH sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The NIH shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the NIH determines that the LICENSEELicensee: 1NIH Patent License Agreement--Exclusive Model 10-2005 (updated 8-2012) Page 13 of 28 Final Lion Biotechnologies, Inc. February 2, 2015
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the NIH’s satisfaction that the LICENSEE 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 reasonably accessible 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 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 reasonable concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the NIH’s reasonable 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 commercially 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 for a sublicense on commercially reasonable terms and conditions.
13.8 The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee. NIH Patent License Agreement--Exclusive Model 10-2005 (updated 8-2012) Page 14 of 28 Final Lion Biotechnologies, Inc. February 2, 2015
13.9 Within thirty (30) days of receipt of written notice of the NIH's unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated NIH official. The decision of the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any 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 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 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 reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent License Agreement (Lion Biotechnologies, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or any licenses Agreement in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEE: 1Licensee:
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHSthe IC's satisfaction that the LICENSEE Licensee has taken, or can be expected to take within a reasonable time, effective steps toto 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
(e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
Appears in 1 contract
Sources: Patent License Agreement (Cartesian Therapeutics, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights, or U.S. Orphan Drug Exclusivity unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS sixty (60) the IC [***] days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEE: 1Licensee:
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE 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 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 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 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 When the public health and safety so require, and after written notice to the Licensee providing the Licensee a [***] day opportunity to respond, the IC 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 IC shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee.
13.8 The IC reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.9 Within [***] days of receipt of written notice of the IC’s unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated IC official or designee. The decision of the designated IC official or designee shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be accessible.
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 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, 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 reporting requirement is not fulfilled.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 This AGREEMENT is effective when signed by all Parties (on the "effective date") 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 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in In the event that LICENSEE Licensee is in default in the performance of any material obligation obligations under this AGREEMENT, including but not limited to the obligations listed in Article 13.05, and if the default has not been remedied remedied, within ninety (90) days after the date of notice in writing of such default, PHS may terminate this AGREEMENT by written notice.
13.03 In the event that 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 and pursue outstanding amounts owed through procedures provided by the Federal Debt Collection Actof a third party's intention to file an involuntary petition in bankruptcy, LICENSEE shall immediately notify PHS in writing.
13.04 LICENSEE shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B AGREEMENT and/or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS shall specifically have the right to terminate or modify, at its option, this AGREEMENT, if PHS determines that the LICENSEE: 1) is not executing the COMMERCIAL DEVELOPMENT PLAN submitted with its request for a license license, as amended or modified at the pertinent time, and the LICENSEE cannot otherwise demonstrate to PHS's 'S satisfaction that the LICENSEE has taken, taken or can be expected to take within a reasonable time, effective steps toto achieve practical application of the LICENSED PRODUCTS or LICENSED PROCESSES; 2) has not achieved the Benchmarks, as amended or modified at the pertinent time; 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 the domestic production requirement of Paragraph 5.02
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in . In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE . In the event that 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, the Licensee shall immediately notify the IC in writing. The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEELicensee: 1) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE 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; has not achieved the Benchmarks as may be modified under Paragraph 9.2; 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; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 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 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.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS 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 NIH may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that the Licensee (i) becomes insolvent, (ii) files a petition in bankruptcy, or has such a petition filed against it and, in either case, such petition is not dismissed within sixty (60) days, the Licensee shall immediately notify the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the NIH sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The NIH shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the NIH determines that the LICENSEELicensee: 1NIH Patent License Agreement--Exclusive Model 10-2005 (updated 8-2012) Page 13 of 28 Final Lion Biotechnologies, Inc. February 2, 2015 03424-0001 266291.2
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the NIH’s satisfaction that the LICENSEE 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 reasonably accessible 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 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 reasonable concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the NIH’s reasonable 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 commercially 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 for a sublicense on commercially reasonable terms and conditions.
13.8 The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee. NIH Patent License Agreement--Exclusive Model 10-2005 (updated 8-2012) Page 14 of 28 Final Lion Biotechnologies, Inc. February 2, 2015 03424-0001 266291.2
13.9 Within thirty (30) days of receipt of written notice of the NIH's unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated NIH official. The decision of the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any 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 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 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 reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent License Agreement (Lion Biotechnologies, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS 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 NIH may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that the Licensee (i) becomes insolvent, (ii) files a petition in bankruptcy, or has such a petition filed against it and, in either case, such petition is not dismissed within sixty (60) days, the Licensee shall immediately notify the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the NIH sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The NIH shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the NIH determines that the LICENSEELicensee: 1NIH Patent License Agreement--Exclusive Model 10-2005 (updated 8-2012) Page 15 of 31 Final Lion Biotechnologies, Inc. February 4, 2015 03424-0001 266294.2
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the NIH’s satisfaction that the LICENSEE 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 reasonably accessible 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 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 reasonable concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the NIH’s reasonable 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 commercially 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 for a sublicense on commercially reasonable terms and conditions.
13.8 The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee. NIH Patent License Agreement--Exclusive Model 10-2005 (updated 8-2012) Page 16 of 31 Final Lion Biotechnologies, Inc. February 4, 2015 03424-0001 266294.2
13.9 Within thirty (30) days of receipt of written notice of the NIH's unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated NIH official. The decision of the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any 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 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 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 reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent License Agreement (Lion Biotechnologies, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS 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 NIH may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that the Licensee (i) becomes insolvent, (ii) files a petition in bankruptcy, or has such a petition filed against it and, in either case, such petition is not dismissed within sixty (60) days, the Licensee shall immediately notify the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the NIH sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The NIH shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the NIH determines that the LICENSEELicensee: 1NIH Patent License Agreement—Exclusive Model 10-2005 (updated 8-2012) Page 15 of 31 Final Lion Biotechnologies, Inc. February 4, 2015
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the NIH’s satisfaction that the LICENSEE 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 reasonably accessible 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 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 reasonable concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the NIH’s reasonable 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 commercially 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 for a sublicense on commercially reasonable terms and conditions.
13.8 The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee. NIH Patent License Agreement—Exclusive Model 10-2005 (updated 8-2012) Page 16 of 31 Final Lion Biotechnologies, Inc. February 4, 2015
13.9 Within thirty (30) days of receipt of written notice of the NIH's unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated NIH official. The decision of the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any 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 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 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 reporting requirement is not fulfilled.
Appears in 1 contract
Sources: Patent License Agreement (Lion Biotechnologies, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the NIH may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, or receives notice of a third party's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any Licensed Fields of Use in any country or territory by giving PHS sixty (60) days the NIH [***] written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The NIH shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement by written notice to the Licensee, if PHS the NIH reasonably determines that the LICENSEE: 1Licensee:
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the NIH’s satisfaction that the LICENSEE A-107-2014 NIH Patent License Agreement--Exclusive 11 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.
13.8 The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement upon written notice to the Licensee if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee within [***] following written notice from the NIH.
13.9 Within [***] of receipt of written notice of the NIH's unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated NIH official. The decision of the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.
13.10 Within [***] 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 reporting requirement is not fulfilled. A-107-2014 NIH Patent License Agreement--Exclusive 12
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS Leidos Biomedical may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by other procedures, including but not limited to judicial collection. CONFIDENTIAL Patent License Agreement – Exclusive Page 13 of 28 [Final] [Theras] [Friday, December 14, 2018] 1 [Page 13 of 28] ●
13.3 In the Federal Debt Collection Actevent that 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, the Licensee shall immediately notify Leidos Biomedical in writing.
13.04 LICENSEE 13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS sixty (60) Leidos Biomedical [***] days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.,
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 Leidos Biomedical shall specifically have the right to terminate or modifymodify (subject to Licensee’s agreement to such modification), at its option, this AGREEMENTAgreement, using the process set forth in Section 13.2, if PHS Leidos Biomedical determines that the LICENSEE: 1Licensee;
(a) is not executing using commercially reasonable efforts to execute the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's satisfaction that the LICENSEE 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.
13.6 In making the determination referenced in ▇▇▇▇▇▇▇▇▇ ▇▇.▇, ▇▇▇▇▇▇ Biomedical 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 ▇▇▇▇▇▇▇▇▇ ▇▇.▇, ▇▇▇▇▇▇ Biomedical shall give written notice to the Licensee providing the Licensee specific notice of, and a [***] day opportunity to respond to, Leidos Biomedical’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate Leidos Biomedical’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to Leidos Biomedical’s satisfaction, Leidos Biomedical may terminate this Agreement.
13.7 When the public health and safety so require, and after written notice to the Licensee providing (he Licensee a [***] day opportunity to respond. Leidos Biomedical 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. Leidos Biomedical shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee. CONFIDENTIAL Patent License Agreement – Exclusive Page 14 of 28 [Final] [Theras] [Friday, December 14, 2018] 1 [Page 14 of 28] ●
13.8 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 Leidos Biomedical 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 Leidos Biomedical pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to Leidos Biomedical or provide Leidos Biomedical with certification of the destruction thereof. The Licensee may not be granted additional Leidos Biomedical licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties parties, unless the provisions of Paragraph 14.16 are not fulfilled, and shall extend, on a Licensed Product-by-Licensed Product (the "effective date"or Licensed Process-by-Licensed Process) and shall extend country-by-country basis, to the expiration of the last to expire of the LICENSED PATENT RIGHTS Licensed Patent Rights that claims such Licensed Product (or Licensed Process) in such country unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or Agreement or any licenses in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC reasonably determines that the LICENSEE: 1Licensee:
(a) is not executing using commercially reasonable efforts to execute the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license license, as may be amended pursuant to Paragraph 9.2, and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE Licensee has taken, or can be expected to take within a reasonable time, effective steps toto achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not used commercially reasonable efforts to achieve 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; [***] NIH Patent License Agreement – Exclusive
(e) is not keeping the Licensed Products or the 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.
Appears in 1 contract
Sources: Patent License Agreement (Dynamics Special Purpose Corp.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1 This AGREEMENT Agreement is effective when signed by all Parties (parties, unless the "effective date") provisions of Paragraph 14.14 are not fulfilled, and shall extend on a country-by-country basis to the later of (a) twenty (20) years from the First Commercial Sale where no Licensed Patent Rights exist or have ceased to exist, or (b) to the expiration of the last to expire of the LICENSED PATENT RIGHTS Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2 In the event that LICENSEE the Licensee (or its Affiliate(s)) is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) calendar days after the date of notice in writing of such the default, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3 In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or any licenses Agreement completely or in any country or territory of the Licensed Territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5 The IC shall specifically have the unilateral right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEE: 1Licensee (or its Affiliate(s)):
(a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE Licensee has taken, or can be expected to take within a reasonable time, effective steps toto achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.1;
(c) has willfully made a false statement of, or willfully omitted, a material fact in the license application, negotiation of this Agreement, or in any report required by this Agreement; has committed a material breach of a covenant or agreement contained in this Agreement; (d)
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.01 13.1. This AGREEMENT Agreement is effective when signed by all Parties (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 Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.02 The terms and conditions of this AGREEMENT shall be considered by PHS to be withdrawn from LICENSEE's consideration and the terms and conditions of this AGREEMENT and the AGREEMENT itself to be null and void, unless this AGREEMENT is executed within sixty (60) days from the date of printing indicated at the bottom of each page.
13.03 Except as otherwise provided in Section 13.05, in 13.2. In the event that LICENSEE the Licensee is in default in the performance of any material obligation obligations under this AGREEMENTAgreement, 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, PHS the IC may terminate this AGREEMENT Agreement by written notice and pursue outstanding amounts royalties owed through procedures provided by the Federal Debt Collection Act.
13.04 LICENSEE 13.3. In the event that 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, the Licensee shall immediately notify the IC in writing.
13.4. The Licensee shall have a unilateral right to terminate this AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or any licenses Agreement in any country or territory by giving PHS the IC sixty (60) days written notice to that effect. Upon any such termination by LICENSEE, LICENSEE and PHS shall each have, in the relevant country or territory, the right to practice the subject matter covered by the LICENSED PATENT RIGHTS determined under United States Patent Law to be jointly owned by the Parties and to license their respective ownership rights to others in all fields, countries or territories not covered by this AGREEMENT.
13.05 Solely to the extent expressly authorized under 37 C.F.R. Section 404.5(b)(9), PHS 13.5. The IC shall specifically have the right to terminate or modify, at its option, this AGREEMENTAgreement, if PHS the IC determines that the LICENSEE: 1Licensee:
a) is not executing the COMMERCIAL DEVELOPMENT PLAN Commercial Development Plan submitted with its request for a license and the LICENSEE Licensee cannot otherwise demonstrate to PHS's the IC’s satisfaction that the LICENSEE 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;
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.
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.
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 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 according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.8. Within thirty (30) days of receipt of written notice of the IC’s unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated the IC official. The decision of the designated IC official shall be the final agency decision. The Licensee may thereafter exercise any 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 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. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, 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 IC licenses if the final reporting requirement is not fulfilled.
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Sources: Patent License Agreement