TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13. 13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. 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 IC in writing. 13.4 The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving IC sixty (60) days written notice to that effect. 13.5 IC shall specifically have the right to terminate or modify, at its option, this Agreement, if IC determines that the Licensee: (a) is not executing the WHO C-TAP Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; (b) has not achieved the Benchmarks as may be modified under Paragraph 9.2; (c) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement; (d) has committed a material breach of a covenant or agreement contained in this (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; 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement. 13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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 3 contracts
Samples: Patent License Non Exclusive and Biological Materials License Non Exclusive, Patent License Non Exclusive and Biological Materials License Non Exclusive, Patent License Non Exclusive and Biological Materials License Non Exclusive
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 . In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 . The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) : is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve 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) this Agreement; 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) or 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(h13.5(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(h13.5(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. 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 3 contracts
Samples: Patent License Agreement, Patent License Agreement, Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee's receipt of written notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS' satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis 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, 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, IC PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC PHS shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s PHS' concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate IC’s PHS' concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to IC’s PHS' satisfaction, IC PITS may terminate this Agreement.
13.7 IC When the public health and safety so require, and after written notice to Licensee providing Licensee a sixty (60) day opportunity to respond, PHS shall have the right to require Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless 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. PITS shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with Licensee.
13.8 PHS reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the 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.
13.8 13.9 Within thirty (30) days of receipt of written notice of IC’s PHS' 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 PHS official. The decision of the designated PHS 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 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 IC PHS 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 PUS 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 IC PHS or provide IC PHS with written certification of the destruction thereof. The Licensee may not be granted additional IC PHS licenses if the final reporting requirement is not fulfilled.
Appears in 2 contracts
Samples: Patent License Agreement (Kinemed Inc), Patent License Agreement (Kinemed Inc)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5Article 13.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.
13.3 13.03 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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The 13.04 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.05 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: 1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICPHS’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this the license Agreement;
(d; 4) has committed a material breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety needs; or
(gor 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.02 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 13.5this determination, IC shall 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 the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement9.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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 2 contracts
Samples: Patent License Agreement (Can-Fite BioPharma Ltd.), Patent License Agreement (Can-Fite BioPharma Ltd.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 7.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 8.8 are not fulfilled, and shall extend to either expire at the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longertime specified in Appendix B, unless sooner previously terminated as provided in under the terms of this Article 137.
13.2 7.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, 7.3 and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC in writing.
13.4 7.3 The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving IC sixty (60) days written notice to that effect.
13.5 IC shall specifically have the right to terminate or modify, at its option, this Agreement, Agreement by written notice if IC determines that the Licensee:the
(a) has not demonstrated that it is not executing the WHO C-TAP Development Plan research plan submitted with its request application for a license and the Licensee or that it has not taken or cannot otherwise demonstrate to IC’s satisfaction that the Licensee has taken, or can be expected to take take, within a reasonable time, effective steps to achieve Practical Application the practical application of the Licensed Products or Licensed Processes;Patent Rights as contemplated by this Agreement; or
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, of or willfully omitted, omitted a material fact in the its application for a 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; 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 7.4 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 this action is necessary to meet the requirements for public use specified by federal Federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.8 7.5 The Licensee shall have a unilateral right to terminate this Agreement by giving the IC sixty (60) days written notice to that effect.
7.6 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. 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 availableaccessible.
13.9 7.7 If either party desires a modification to this Agreement, the parties shall, upon reasonable notice of the proposed modification by the party desiring the change, confer in good faith to determine the desirability of the modification. No modification shall be effective until a written amendment is signed by the signatories to this Agreement or their designees.
7.8 Within ninety (90) days of expiration expiration, termination or termination term extension of this Agreement under this Article 137, a final report shall be submitted by the Licensee. The Licensee shall send the report to the IC at the Mailing Address for Agreement notices indicated on the Signature Page or electronically mailed to the email address indicated on the Signature Page.
(a) The report shall include, but not be limited to, progress on the research and development involving the Licensed Patent Rights, the Licensed Products or the Licensed Processes.
(b) 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. .
(c) If the term of the Agreement is extended at the Licensee’s request, then the IC and the Licensee will negotiate in good faith regarding the schedule for reports regarding the information required in 7.8(a);
(d) If the term of this Agreement is longer than ten (10) years, then the IC may request a status update report after the fifth (5th) year of the Agreement; and
(e) The Licensee may not be granted additional IC licenses if the final this reporting requirement is not fulfilled.
7.9 Paragraphs 4.3, 4.4, 5.4, 6.1-6.5, 7.6, 7.8 and 7.9 of this Agreement shall survive termination of this Agreement.
Appears in 2 contracts
Samples: Non Exclusive Patent License Agreement, Non Exclusive Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 8.8 are not fulfilled, and shall extend to either expire at the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longertime specified in Appendix B, unless sooner previously terminated as provided in under the terms of this Article 13.
13.2 7. In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, 7.3 and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC in writing.
13.4 . The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving IC sixty (60) days written notice to that effect.
13.5 IC shall specifically have the right to terminate or modify, at its option, this Agreement, Agreement by written notice if IC determines that the Licensee:
(a) : has not demonstrated that it is not executing the WHO C-TAP Development Plan research plan submitted with its request application for a license and the Licensee or that it has not taken or cannot otherwise demonstrate to IC’s satisfaction that the Licensee has taken, or can be expected to take take, within a reasonable time, effective steps to achieve Practical Application the practical application of the Licensed Products Patent Rights as contemplated by this Agreement; 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, of or willfully omitted, omitted a material fact in the its application for a 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; 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, 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 this action is necessary to meet the requirements for public use specified by federal Federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.8 . The Licensee shall have a unilateral right to terminate this Agreement by giving the IC sixty (60) days written notice to that effect. 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. 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 accessible. If either party desires a modification to this Agreement, the parties shall, upon reasonable notice of the proposed modification by the party desiring the change, confer in good faith to determine the desirability of the modification. No modification shall be effective until a written amendment is signed by the signatories to this Agreement or their designees. Within ninety (90) days of expiration expiration, termination or termination term extension of this Agreement under this Article 137, a final report shall be submitted by the Licensee. The Licensee shall send the report to the IC at the Mailing Address for Agreement notices indicated on the Signature Page or electronically mailed to the email address indicated on the Signature Page. The report shall include, but not be limited to, progress on the research and development involving the Licensed Patent Rights, the Licensed Products or the Licensed Processes. 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. If the term of the Agreement is extended at the Licensee’s request, then the IC and the Licensee will negotiate in good faith regarding the schedule for reports regarding the information required in 7.8(a); If the term of this Agreement is longer than ten (10) years, then the IC may request a status update report after the fifth (5th) year of the Agreement; and The Licensee may not be granted additional IC licenses if the final this reporting requirement is not fulfilled. Paragraphs 4.3, 4.4, 5.4, 6.1-6.5, 7.6, 7.8 and 7.9 of this Agreement shall survive termination of this Agreement.
Appears in 2 contracts
Samples: Non Exclusive Patent License Agreement, Non Exclusive Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 . In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 . The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) : is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve 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) this Agreement; 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) or 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(h13.5(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(h13.5(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 2 contracts
Samples: Patent License, Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when (“Effective Date”)when signed by all parties, unless the provisions of Paragraph 14.15 14.17 are not fulfilled, and shall extend to either the expiration or termination of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in material default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC Subject to Paragraph 13.5, PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, omitted a material fact in the license application or in any report required by this the license Agreement;
(d) has committed a material breach of a material covenant or material agreement contained in thisthis Agreement;
(e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f) cannot reasonably not, after First Commercial Sale, reasonable satisfy unmet health and safety needs; oror [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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, IC PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC PHS shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to IC’s PHS’ satisfaction, IC PHS, subject to Paragraph 13.8, may modify or terminate this Agreement.
13.7 IC When the public health and safety so require, and after written notice to Licensee providing Licensee a sixty (60) day opportunity to respond, PHS shall have the right to require Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless 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. PHS shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with Licensee.
13.8 Subject to Paragraph 13.8, PHS reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the 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.
13.8 13.9 Within thirty (30) days of receipt of written notice of IC’s PHS’ unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. CFR §404.11, appeal the decision by written submission to the designated IC PHS official. The decision of the designated PHS 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 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 IC PHS 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 PHS 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 IC PHS or provide IC PHS with written certification of the destruction thereof. The Licensee may not be granted additional IC licenses if [*] = Certain confidential information contained in this document, marked by brackets, is filed with the final reporting requirement is not fulfilledSecurities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Appears in 2 contracts
Samples: Patent License Agreement (Globeimmune Inc), Patent License Agreement (Globeimmune Inc)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5Article 13.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.
13.3 13.03 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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee's receipt of written notice.
13.4 The 13.04 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.05 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: I) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS's satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this the license Agreement;
(d; 4) has committed a material breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety needs; or
(gor 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.02 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 13.5this determination, IC shall 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 the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement9.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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 2 contracts
Samples: Asset Assignment Agreement (Compass Biotechnologies Inc.), Asset Assignment Agreement (Cyplasin Biomedical Ltd.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 . In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 '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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 . The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) : is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) ; has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) ; has willfully made a false statement of, or willfully omitted, 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) this Agreement; 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, 5.2 unless waived; or
(h) or 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(h13.5(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(h13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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 2 contracts
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis 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, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day [***] opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s satisfaction, IC the NIH may terminate this Agreement.
13.7 IC 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 NIH Patent License Agreement – Exclusive 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)(35209(d)(3) to terminate or modify this Agreement if it is determined that the 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.
13.8 13.9 Within thirty (30) days of receipt of written notice of ICthe 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 IC NIH official. The decision of the designated the NIH official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be availableaccessible.
13.9 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 expenseexpenses, due to IC 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 IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC NIH licenses if the final reporting requirement is not fulfilled.
Appears in 2 contracts
Samples: Patent License Agreement (Aura Biosciences, Inc.), Patent License Agreement (Aura Biosciences, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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. Furthermore, to the extent allowed under applicable law, the IC shall have the right to terminate this Agreement immediately upon the Licensee’s receipt of written notice; provided, however, that with respect to any petition filed against the Licensee, the IC shall not have the right to terminate this Agreement if the Licensee is able to resolve or obtain the dismissal of such petition within ninety (90) days following the date of such notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis Agreement that has not been remedied within the ninety (90) days 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; or;
(g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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.. NIH Patent License Agreement—Exclusive Model 10-2015 Page 15 of 29 [Final] [Kyverna Therapeutics] [12 May 2021]
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 toto and remedy, 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) within ninety (90) days following written notice from the IC, or otherwise fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this AgreementAgreement upon written notice to the Licensee.
13.7 When the public health and safety so require, and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, the 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 upon written notice to the Licensee if it is determined that the 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 LicenseeLicensee within ninety (90) days following written notice from the IC.
13.8 13.9 Within thirty (30) days of 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 officialofficial 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.
13.9 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 expenseexpenses, 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 have the right to offer for sale and sell any existing inventory of Licensed Products for […***…] following the effective termination date of this Agreement, subject to the royalty obligations as set forth in Appendix C. After this […***…] period, the Licensee shall return all remaining Materials, Licensed Products or Products, and 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 2 contracts
Samples: Patent License Agreement (Kyverna Therapeutics, Inc.), Patent License Agreement (Kyverna Therapeutics, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, licensed patent rights unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee LICENSEE is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Actnotice.
13.3 At least 30 days prior to filing a petition in bankruptcy LICENSEE must inform PHS of its intention to file the petition in bankruptcy or of a third party’s intention to file an involuntary petition in bankruptcy.
13.4 In the event that the Licensee 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 LICENSEE shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement by giving LICENSEE written notice. Termination of this Agreement is effective upon LICENSEE’s receipt of the written notice.
13.4 The Licensee 13.5 LICENSEE shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.6 PHS shall specifically have the right to terminate or modify, modify at its option, option this Agreement, Agreement if IC PHS determines that the Licensee:
LICENSEE: (a1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee LICENSEE cannot otherwise demonstrate to ICPHS’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; 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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 2 contracts
Samples: Sublicense Agreement (Somanta Pharmaceuticals Inc.), Sublicense Agreement (Somanta Pharmaceuticals Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement AGREEMENT is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, LICENSED PATENT RIGHTS unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee LICENSEE is in default in the performance of any material obligations under this AgreementAGREEMENT, including but not limited to the obligations listed in Paragraph 13.5Article 13.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement AGREEMENT by written notice and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.
13.3 13.03 In the event that the Licensee LICENSEE becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s 's intention to file an involuntary petition in bankruptcy, the Licensee LICENSEE shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this AGREEMENT immediately upon LICENSEE'S receipt of written notice.
13.4 The Licensee 13.04 LICENSEE shall have a unilateral right to terminate this Agreement AGREEMENT and/or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.05 PHS shall specifically have the right to terminate or modify, at its option, this AgreementAGREEMENT, if IC PHS determines that the Licensee:
(aLICENSEE: 1) is not executing the WHO C-TAP Development Plan COMMERCIAL DEVELOPMENT PLAN submitted with its request for a license and the Licensee LICENSEE cannot otherwise demonstrate to IC’s PHS's satisfaction that the Licensee LICENSEE has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application PRACTICAL APPLICATION of the Licensed Products LICENSED PRODUCTS or Licensed Processes;
(bLICENSED PROCESSES; 2) has not achieved the Benchmarks BENCHMARKS as may be modified under Paragraph 9.2;
(c9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement;
(dthe license AGREEMENT; 4) has committed a material breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products LICENSED PRODUCTS or Licensed Processes LICENSED PROCESSES reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety needs; or
(gor 7) 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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.5.02
Appears in 2 contracts
Samples: Patent License Agreement (Genvec Inc), Patent License Agreement (Genvec Inc)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 1313 [***].
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC the NIAID may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC the NIAID in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory [***] by giving IC the NIAID sixty (60) days written notice to that effect.
13.5 IC [***] the NIAID shall specifically have the right to terminate or modify, at its option, this Agreement, if IC determines that the Licensee:
(a) is not executing [***] the WHO C-TAP Commercial Development Plan submitted with its request for a license [***] and the Licensee cannot otherwise demonstrate to ICNIAID’s [***] satisfaction that the Licensee has taken[***], or can be expected to take [***] within a reasonable time, effective steps [***] to achieve the Practical Application of the Licensed Products or the Licensed ProcessesProcess;
(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, omitted a material fact in the license application or in any report required by this Agreement;this
(d) has committed a an [***] material breach of a covenant or agreement contained in thisthis Agreement;
(e) is not keeping the Licensed Products or the Licensed Processes reasonably available to the public after commercial use commences;; or
(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, 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 Agreementwaived [***].
13.6 In making the determination any determinations referenced in Paragraph 13.5, IC 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 Agreement under Paragraph 13.5, IC the NIAID shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIAID’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)—13.5(g). If the Licensee fails to alleviate IC’s concerns as to the items [***] referenced in 13.5(a)-13.5(h13.5(a)—13.5(g) or [***], fails to initiate corrective action to ICthe NIAID’s [***] satisfaction, IC the NIAID may terminate this Agreement.
13.7 IC 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 NIAID 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 NIAID shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee [***].
13.8 The NIAID reserves the right according to 35 U.S.C. §209(d)(3U.S.C.§209(d)(3) to terminate or modify this Agreement if it is determined that the 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 LicenseeLicensee [***].
13.8 13.9 Within thirty (30) days of receipt of written notice of ICthe NIAID’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 officialNIAID official or designee. The decision of the designated NIAID official or designee shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be availableaccessible.
13.9 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 IC the NIAID shall become immediately due and payable upon termination or expiration. [***] If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with the NIAID pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC the NIAID or provide IC the NIAID with written certification of the destruction thereof. The Licensee may not be granted additional IC NIAID licenses if the final reporting requirement is not fulfilled.
Appears in 2 contracts
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
13.3 In the event that the Licensee becomes insolventLicensee, files a petition in bankruptcy, or has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC the NIH in writing. Furthermore, to the extent allowed under applicable law, the NIH shall have the right to terminate this Agreement immediately upon the Licensee’s receipt of written notice; provided, however, that with respect to any petition filed against the Licensee, the NIH shall not have the right to terminate this Agreement if the Licensee is able to resolve or obtain the dismissal of such petition within […***…] following the date of such notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any Licensed Field of Use as specified in Appendix B in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this AgreementAgreement by written notice to the Licensee, if IC the NIH determines in good faith that the Licensee:: A-294-2011 NIH Patent License Agreement - Exclusive
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s the NIH’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis Agreement that has not been remedied within the ninety (90) days period set forth in Paragraph 13.2 above;
(e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f) cannot reasonably satisfy unmet health and safety needs; or
(gf) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICto remedy the items referenced in Paragraphs 13.5(a)-13.5(g). If the Licensee fails to alleviate the NIH’s concerns as to the items referenced in 13.5(a)-13.5(h). If Paragraphs 13.5(a)-13.5(g) within ninety (90) days following written notice from the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) NIH or otherwise fails to initiate corrective action to ICthe NIH’s satisfaction, IC the NIH may terminate this AgreementAgreement upon written notice to the Licensee.
13.7 IC When the public health and safety so require and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, the NIH shall have the right to require the Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless the Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. The NIH shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee.
13.8 The NIH reserves the right 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 the 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 LicenseeLicensee within ninety (90) days following written notice from the NIH.
13.8 13.9 Within thirty (30) days of after receipt of written notice of ICthe 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 IC 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.. A-294-2011 NIH Patent License Agreement - Exclusive
13.9 13.10 Within ninety (90) days of […***…] after 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 IC 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 of this Agreement, the Licensee shall have the right to offer for sale and sell any existing inventory of Licensed Products for […***…] following the effective termination date of this Agreement, subject to the royalty obligations as set forth in Appendix C. After this […***…] period, the Licensee shall return all remaining Licensed Products or other materials included within the Licensed Patent Rights to IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC NIH licenses if the final reporting requirement is not fulfilled.
Appears in 2 contracts
Samples: Patent License Agreement (Kite Pharma, Inc.), Patent License Agreement (Kite Pharma, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 '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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 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, 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(h13.5(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(h13.5(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 the 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.
13.8 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 officialofficial 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 availableaccessible.
13.9 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 expenseexpenses, 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 2 contracts
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement AGREEMENT is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, LICENSED PATENT RIGHTS unless sooner terminated as provided in this Article 13.
13.2 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 In the event that the Licensee LICENSEE is in default in the performance of any material obligations under this AgreementAGREEMENT, including but not limited to the obligations listed in Paragraph 13.513.06, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement AGREEMENT by written notice and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.
13.3 13.04 In the event that the Licensee LICENSEE becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s 's intention to file an involuntary petition in bankruptcy, the Licensee LICENSEE shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this AGREEMENT immediately upon LICENSEE's receipt of written notice.
13.4 The Licensee 13.05 LICENSEE shall have a unilateral right to terminate this Agreement AGREEMENT in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.06 PHS shall specifically have the right to terminate or modify, at its option, this AgreementAGREEMENT, if IC PHS determines that the Licensee:
(aLICENSEE: 1) is not executing the WHO C-TAP Development Plan submitted with its request for a license COMMERCIAL DEVELOPMENT PLAN attached in Appendix E and the Licensee LICENSEE cannot otherwise demonstrate to IC’s PHS's satisfaction that the Licensee LICENSEE has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application PRACTICAL APPLICATION of the Licensed Products LICENSED PRODUCTS or Licensed Processes;
(bLICENSED PROCESSES; 2) has not achieved the Benchmarks 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; 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 Agreement9.
13.6 In making the determination referenced in Paragraph 13.5, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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 2 contracts
Samples: Patent License Agreement (Inhibitex Inc), Patent License Agreement (Inhibitex Inc)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 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 thirty (30) days from the date of printing indicated at the bottom of each page.
13.03 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.513.06, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.
13.3 13.04 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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The 13.05 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC sixty PHS thirty (6030) days written notice to that effect.
13.5 IC 13.06 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: 1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICPHS’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products Product(s) or Licensed Processes;
(bProcess(es); 2) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this the license Agreement;
(d; 4) has committed a material breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products Product(s) or Licensed Processes Process(es) reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety needs; or
(gor 7) 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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 2 contracts
Samples: Sublicense and License Agreement (Neopharm Inc), Sublicense and License Agreement (Neopharm Inc)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the defaultdefault or if not reasonably capable of remedy within such period, IC Licensee has not taken substantial steps to remedy the alleged default within such ninety (90) day period, PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Procedure Act.
13.3 In the event that the Licensee (i) becomes insolvent, or (ii) 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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.29.2 and is not reasonably likely to achieve them;
(c) has willfully made a material false statement of, or willfully omitted, 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 thisthis Agreement;
(e) is not keeping Licensed Products or Licensed Processes within the scope of Group I Licensed Patent Rights reasonably available 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, 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, IC PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC PHS shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate IC’s PHS’ reasonable concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to IC’s PHS’ reasonable satisfaction, IC PHS may terminate this Agreement.
13.7 IC reserves When the public health and safety so require, and after written notice to Licensee providing Licensee a sixty (60) day opportunity to respond, PHS shall have the right according to 35 U.S.C. §209(d)(3) require Licensee to terminate or modify this Agreement if it is determined grant sublicenses to responsible applicants, on commercially reasonable terms, in any Licensed Fields of Use under the Group I Licensed Patent Rights, unless Licensee can reasonably demonstrate that the action is necessary to meet the requirements for public use specified by federal regulations issued after the date granting of the license and these requirements are sublicense would not reasonably satisfied by materially increase the Licensee.
13.8 Within thirty (30) days of receipt of written notice of 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 availability to the designated IC official. The decision public of the designated official shall be subject matter of 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Group I Licensed Patent Rights to IC or provide IC Rights. PHS shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with written certification of the destruction thereof. The Licensee may not be granted additional IC licenses if the final reporting requirement is not fulfilledfor a sublicense on commercially reasonable terms and conditions.
Appears in 2 contracts
Samples: Patent License Agreement (Bavarian Nordic a/S / ADR), Patent License Agreement (Bavarian Nordic a/S / ADR)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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. Furthermore, to the extent allowed under applicable law, the IC shall have the right to terminate this Agreement immediately upon the Licensee’s receipt of written notice; provided, however, that with respect to any petition filed against the Licensee, the IC shall not have the right to terminate this Agreement if the Licensee is able to resolve or obtain the dismissal of such petition within ninety (90) days following the date of such notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis Agreement that has not been remedied within the ninety (90) days 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; or;
(g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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 NIH Patent License Agreement—Exclusive notice of, and a ninety (90) day opportunity to respond toto and remedy, 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) within ninety (90) days following written notice from the IC, or otherwise fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement.
13.7 IC reserves the right according Agreement upon written notice 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 13.7 When the public health and safety so require, and after written notice of IC’s unilateral decision to modify or terminate this Agreementthe Licensee providing the Licensee a sixty (60) day opportunity to respond, 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, have the right to require the Licensee shall return all to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Products or other materials included within Fields of Use under the Licensed Patent Rights to IC or provide IC with written certification Rights, unless the Licensee can reasonably demonstrate that the granting of the destruction thereof. The Licensee may sublicense would not be granted additional IC licenses if materially increase the final reporting requirement is not fulfilled.availability to the public of the subject matter of the
Appears in 2 contracts
Samples: Patent License Agreement (Kyverna Therapeutics, Inc.), Patent License Agreement (Kyverna Therapeutics, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the defaultdefault or if not reasonably capable of remedy within such period, IC Licensee has not taken substantial steps to remedy the alleged default within such ninety (90) day period, NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection ActProcedure Act .
13.3 In the event that the Licensee (i) becomes insolvent, or (ii) 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 IC the NIH in writing. Furthermore, NIH shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.29.2 and is not reasonably likely to achieve them;
(c) has willfully made a material false statement of, or willfully omitted, 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 thisthis Agreement;
(e) is not keeping the Licensed Products or the Licensed Processes within the scope of Group I Licensed Patent Rights reasonably available 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, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s reasonable concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s reasonable satisfaction, IC the NIH may terminate this Agreement.
13.7 IC reserves 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 according to 35 U.S.C. §209(d)(3) require the Licensee to terminate or modify this Agreement if it is determined grant sublicenses to responsible applicants, on commercially reasonable terms, in any Licensed Fields of Use under the Group I Licensed Patent Rights, unless the Licensee can reasonably demonstrate that the action is necessary to meet the requirements for public use specified by federal regulations issued after the date granting of the license and these requirements are sublicense would not reasonably satisfied by materially increase the Licensee.
13.8 Within thirty (30) days of receipt of written notice of 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 availability to the designated IC official. The decision public of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide IC with written certification subject matter of the destruction thereof. The Licensee may not be granted additional IC licenses if the final reporting requirement is not fulfilled.Group I
Appears in 2 contracts
Samples: Patent License Agreement (Bavarian Nordic a/S / ADR), Patent License Agreement (Bavarian Nordic a/S / ADR)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.17 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 . In the event that the Licensee LICENSEE is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days 30 after the date of notice in writing of the default, IC VA may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
13.3 , 15 U.S.C. § 1692 et seq. In the event that the Licensee LICENSEE becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s 's intention to file an involuntary petition in bankruptcy, the Licensee LICENSEE shall immediately notify IC VA in writing.
13.4 The Licensee . Furthermore, VA shall have the right to terminate this Agreement immediately upon LICENSEE's receipt of written notice. LICENSEE shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC sixty (60) 180 days written notice to that effect.
13.5 IC . VA shall specifically have the right to terminate or modify, at its option, this Agreement, if IC VA determines that the Licensee:
(a) LICENSEE: is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee LICENSEE cannot otherwise demonstrate to ICVA’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, omitted a material fact in the license application or in any report required by this the license Agreement;
(d) ; has committed a material breach of a covenant or agreement contained in this
(e) this Agreement; 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) or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.2 unless waived; or
(h) has been found by a court of competent jurisdiction to have violated . When the Federal antitrust laws in connection with its performance under this Agreement.
13.6 In making the determination referenced in Paragraph 13.5public health and safety so require, 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, IC shall give after written notice to the Licensee LICENSEE providing the Licensee specific notice of, and LICENSEE a ninety sixty (9060) day opportunity to respond torespond, IC’s concerns as VA shall have the right to require LICENSEE to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless LICENSEE can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the items referenced public of the subject matter of the Licensed Patent Rights. VA shall not require the granting of a sublicense unless the responsible applicant has first negotiated in 13.5(a)-13.5(h)good faith with LICENSEE. If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 IC VA reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the 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.
13.8 LICENSEE. Within thirty (30) days of receipt of written notice of IC’s VA's unilateral decision to modify or terminate this Agreement, the Licensee LICENSEE may, consistent with the provisions of 37 C.F.R. CFR §404.11, appeal the decision by written submission to the designated IC VA official. The decision of the designated VA official shall be the final agency decision. The Licensee 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 LicenseeLICENSEE. 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 IC VA 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 VA pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, the Licensee LICENSEE shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC VA or provide IC VA 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 2 contracts
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.17 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the defaultdefault or if not reasonably capable of remedy within such period, IC Licensee has not taken substantial steps to remedy the alleged default within such ninety (90) day period, PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
13.3 In the event that the Licensee (i) becomes insolvent, or (ii) files a petition in bankruptcy, bankruptcy or has such a petition filed against itit and, determines to file a in either case, such petition in bankruptcyis not dismissed within sixty (60) days, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved 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, omitted a material fact in the license application or in any report required by this the license Agreement;
(d) has committed a material breach of a covenant or agreement contained in thisthis Agreement;
(e) is not keeping Licensed Products or Licensed Processes within the scope of the Group I Licensed Patent Rights reasonably available accessible to the public after commercial use commencescommences in the United States;
(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, 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, IC PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC PHS shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate IC’s PHS’ reasonable concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to IC’s PHS’ reasonable satisfaction, IC PHS may terminate this Agreement.
13.7 IC reserves When the public health and safety so require, and after written notice to Licensee providing Licensee a sixty (60) day opportunity to respond, PHS shall have the right according to 35 U.S.C. §209(d)(3) require Licensee to terminate or modify this Agreement if it is determined grant sublicenses to responsible applicants, on commercially reasonable terms, in any Licensed Fields of Use under the Group I Licensed Patent Rights, unless Licensee can reasonably demonstrate that the action is necessary to meet the requirements for public use specified by federal regulations issued after the date granting of the license and these requirements are sublicense would not reasonably satisfied by materially increase the Licensee.
13.8 Within thirty (30) days of receipt of written notice of 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 availability to the designated IC official. The decision public of the designated official shall be subject matter of 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Group I Licensed Patent Rights to IC or provide IC Rights. PHS shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with written certification of the destruction thereof. The Licensee may not be granted additional IC licenses if the final reporting requirement is not fulfilledfor a sublicense on commercially reasonable terms and conditions.
Appears in 2 contracts
Samples: Patent License Agreement (Bavarian Nordic a/S / ADR), Patent License Agreement (Bavarian Nordic a/S / ADR)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 1313 [***].
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC the NIAID may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC the NIAID in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory [***] by giving IC the NIAID sixty (60) days written notice to that effect.
13.5 IC [***] the NIAID shall specifically have the right to terminate or modify, at its option, this Agreement, if IC determines that the Licensee:
(a) is not executing [***] the WHO C-TAP Commercial Development Plan submitted with its request for a license [***] and the Licensee cannot otherwise demonstrate to ICNIAID’s [***] satisfaction that the Licensee has taken[***], or can be expected to take [***] within a reasonable time, effective steps [***] to achieve the Practical Application of the Licensed Products or the Licensed ProcessesProcess;
(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, omitted a material fact in the license application or in any report required by this Agreement;
(d) has committed a an [***] material breach of a covenant or agreement contained in thisthis Agreement;
(e) is not keeping the Licensed Products or the Licensed Processes reasonably available to the public after commercial use commences;; or
(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, 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 Agreementwaived [***].
13.6 In making the determination any determinations referenced in Paragraph 13.5, IC 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 Agreement under Paragraph 13.5, IC the NIAID shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIAID’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)—13.5(g). If the Licensee fails to alleviate IC’s concerns as to the items [***] referenced in 13.5(a)-13.5(h13.5(a)—13.5(g) or [***], fails to initiate corrective action to ICthe NIAID’s [***] satisfaction, IC the NIAID may terminate this Agreement.
13.7 IC 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 NIAID 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 NIAID shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee [***].
13.8 The NIAID reserves the right according to 35 U.S.C. §209(d)(3U.S.C.§209(d)(3) to terminate or modify this Agreement if it is determined that the 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 LicenseeLicensee [***].
13.8 13.9 Within thirty (30) days of receipt of written notice of ICthe NIAID’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 officialNIAID official or designee. The decision of the designated NIAID official or designee shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be availableaccessible.
13.9 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 IC the NIAID shall become immediately due and payable upon termination or expiration. [***] If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with the NIAID pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC the NIAID or provide IC the NIAID with written certification of the destruction thereof. The Licensee may not be granted additional IC NIAID licenses if the final reporting requirement is not fulfilled.
Appears in 2 contracts
Samples: Patent License Agreement (AbCellera Biologics Inc.), Patent License Agreement (AbCellera Biologics Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve 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; 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(h13.5(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(h13.5(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. 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 2 contracts
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all partiesparties “Effective Date”, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) [**] days after the date of notice in writing of the default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan Plan, as may be amended from time to time in accordance with the provisions of Paragraphs 9.2 and 14.4, submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks Benchmarks, as may be amended from time to time in accordance with the provisions of Paragraphs 9.2 and 14.4, 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 thisthis 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; 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, IC PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC PHS shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) [**] day opportunity to respond to, IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to IC’s PHS’ satisfaction, IC PHS may terminate this Agreement.
13.7 IC PHS 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 IC’s PHS’ unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. CFR §404.11, appeal the decision by written submission to the designated IC PHS official. The decision of the designated PHS 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 IC PHS 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 PHS 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 IC PHS or provide IC PHS 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 2 contracts
Samples: Patent License Agreement (Merrimack Pharmaceuticals Inc), Patent License Agreement (Merrimack Pharmaceuticals Inc)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve 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; 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(h13.5(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(h13.5(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
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 . In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC the NIH in writing.
13.4 . The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC . The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:
(a) : is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) ; has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) ; has willfully made a false statement of, or willfully omitted, 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) this Agreement; 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) or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s satisfaction, IC the NIH may terminate this Agreement.
13.7 IC . 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 the 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.
13.8 . Within thirty (30) days of receipt of written notice of IC’s 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 IC 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 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 expenseexpenses, due to IC 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 IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC NIH licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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. To the extent allowed under applicable law, the IC shall have the right to terminate this Agreement immediately upon the Licensee’s receipt of written notice. However, with respect to any petition(s) filed against the Licensee, Licensee shall have [***] to resolve or obtain the dismissal of such petition. If resolution or dismissal of the petition(s) is not achieved in the allotted period, IC shall have the right to immediately terminate this Agreement.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this AgreementAgreement by written notice to the Licensee, if the IC determines in good faith that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s reasonable satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis Agreement that has not been remedied within the ninety (90) 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; or
(gf) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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(h13.5(a)-13.5(f). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(f) within [***] following written notice from the IC or fails to initiate corrective action to the IC’s reasonable satisfaction, the IC may terminate this Agreement.
13.7 IC reserves the right according Agreement upon written notice 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 13.7 When the public health and safety so require, and after written notice of IC’s unilateral decision to modify or terminate this Agreementthe Licensee providing the Licensee a [***] opportunity to respond, 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, have the right to require the Licensee shall return all to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Products or other materials included within Fields of Use under the Licensed Patent Rights to IC or provide IC with written certification Rights, unless the Licensee can reasonably demonstrate that the granting of the destruction thereof. The Licensee may sublicense would not be granted additional IC licenses if materially increase the final reporting requirement is not fulfilled.availability to the public of the subject matter of the
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5Article 13.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.
13.3 13.03 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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee's receipt of written notice.
13.4 The 13.04 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.05 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: 1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS's satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this the license Agreement;
(d; 4) has committed a material breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety needs; or
(gor 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.02 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 13.5this determination, IC shall 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 the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement9.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
Samples: Patent License Agreement (Targeted Genetics Corp /Wa/)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement AGREEMENT is effective when signed by all parties, unless Parties (the provisions of Paragraph 14.15 are not fulfilled, "effective date") and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, LICENSED PATENT RIGHTS unless sooner terminated as provided in this Article 13.
13.2 In 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 the Licensee LICENSEE is in default in the performance of any material obligations obligation under this Agreement, including but not limited to the obligations listed in Paragraph 13.5AGREEMENT, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement AGREEMENT by written notice and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.
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 IC in writing.
13.4 The Licensee 13.04 LICENSEE shall have a unilateral right to terminate this Agreement AGREEMENT, any of the LICENSED FIELDS OF USE in Appendix B and/or any licenses in any country or territory by giving IC 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.
13.5 IC 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 AgreementAGREEMENT, if IC PHS determines that the Licensee:
(aLICENSEE: 1) is not executing the WHO C-TAP Development Plan COMMERCIAL DEVELOPMENT PLAN submitted with its request for a license and the Licensee LICENSEE cannot otherwise demonstrate to IC’s PHS'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; 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
Samples: Patent License Agreement (Millennium Pharmaceuticals Inc)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5Article 13.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.. PHS Patent License Agreement - Exclusive CONFIDENTIAL (L-216-00/0)
13.3 13.03 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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The 13.04 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.05 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: 1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and modified from time-to-time as described in Appendix E, and the Licensee cannot otherwise demonstrate to ICPHS’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c9.02, and modified from time-to-time as described in Appendix E; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this the license Agreement;
(d; 4) has committed a material breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety needs; or
(gor 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.02 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 13.5this determination, IC shall 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 the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement9.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days [***] after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 in any country or territory by giving the IC sixty (60) days [***] written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve 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 thisthis 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; 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.. A-256-2020 X-000-0000-0 XXX Patent License Agreement Nonexclusive – Sublicensable CONFIDENTIAL
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(h13.5(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(h13.5(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. 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. Unless otherwise specifically provided for If terminated under this AgreementArticle 13, upon sublicensees may elect to convert their sublicenses to direct licenses with the IC pursuant to Paragraph 4.3. Upon termination or expiration of this Agreement, the Licensee shall shall:
(a) 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; or
(b) if the Licensee has existing inventory of Licensed Products at the time of expiration or termination of this Agreement and desires to sell said inventory after expiration or termination of this Agreement, the Licensee shall deem said inventory as sold at the then-current list price, or at [***] if no products had been sold, in the final report, and the earned royalties on said inventory shall become immediately due and payable. The Licensee may not be granted additional IC licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License Agreement (Cellular Biomedicine Group, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Actnotice.
13.3 13.03 At least thirty (30) days prior to filing a petition in bankruptcy, Licensee must inform PHS in writing of its intention to file the petition in bankruptcy or of a third party's intention to file an involuntary petition in bankruptcy.
13.04 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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement by giving Licensee written notice. Termination of this Agreement is effective upon Licensee's receipt of the written notice.
13.4 The 13.05 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC PHS sixty (60) days days' written notice to that effect.
13.5 IC 13.06 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: 1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS's satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application practical application of the Licensed Products or Licensed Processes;
(b; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement;
(dthe license agreement; 4) has committed a material substantial breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety needs; or
(g) cannot reasonably justify a failure to comply with the domestic production requirement or NIH Office of Paragraph 5.2Technology Transfer PHS PATENT LICENSE AGREEMENT - EXCLUSIVE MODEL 940110 - Page 12 - FINAL - MediChem Research, 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 13.5Inc. - May 5, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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.1995
Appears in 1 contract
Samples: Joint Venture Agreement (Advanced Life Sciences Holdings, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 . In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC the NIH in writing.
13.4 . The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC . The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:
(a) : is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) ; has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) ; has willfully made a false statement of, or willfully omitted, 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) this Agreement; 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) or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s satisfaction, IC the NIH may terminate this Agreement.
13.7 IC . 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 the 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.
13.8 . Within thirty (30) days of receipt of written notice of IC’s 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 IC the NIH official. The decision of the designated the 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 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 IC 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 IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC the NIH licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Start Up Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of a Valid Claim within the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) [***] days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 partyThird 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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate this Agreement pursuant to Paragraph 13.6, such 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 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 modify, at (iii) upon Licensee’s written notification of its option, acceptance of the termination of this Agreement, if the IC reasonably determines that the Licensee:
(a) is not executing using commercially reasonable efforts to execute the WHO C-TAP Commercial Development Plan submitted with its request for a license attached as Appendix E of this Agreement) and the Licensee cannot otherwise demonstrate to the IC’s reasonable satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;; 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, 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 thisthis 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; or;
(g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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 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 the 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.
13.8 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 officialofficial 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.accessible. A-440-2021 NIH Patent License Agreement--Exclusive Model 10-2015 Page 20 of 28 [Draft v1] [Sana] [12/16/2021]
13.9 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 expenseexpenses, due to the IC shall become immediately due and payable upon within [***] days of termination or expirationexpiration . 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 return destroy all Licensed Products or other materials included within the Licensed Patent Rights to IC or and, upon written request, 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
Samples: Patent License Agreement (Sana Biotechnology, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days [***] after the date of notice in writing of the default, IC the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any Licensed Fields of Use in any country or territory by giving IC sixty (60) days the NIH [***] written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this AgreementAgreement by written notice to the Licensee, if IC the NIH reasonably determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis 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; or;
(g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day [***] opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or within [***] following written notice from the NIH or otherwise fails to initiate corrective action to ICthe NIH’s satisfaction, IC the NIH may terminate this AgreementAgreement upon written notice to the Licensee.
13.7 IC 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 the 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 LicenseeLicensee within [***] following written notice from the NIH.
13.8 13.9 Within thirty (30) days [***] of receipt of written notice of IC’s 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 IC 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 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 expenseexpenses, due to IC 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 have the right to offer for sale and sell any existing inventory of Licensed Products or other materials included within for a period of [***] following the Licensed Patent Rights effective termination date of this Agreement, subject to IC or provide IC with written certification of the destruction thereof. royalty obligations as set forth in Appendix C. The Licensee may not be granted additional IC NIH licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 . In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 . The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) : is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve 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) this Agreement; 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) or 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(h13.5(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(h13.5(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. 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
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 13.17 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, LICENSED PATENT RIGHTS unless sooner terminated as provided in this Article 13.
13.2 . In the event that the Licensee LICENSEE is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.512.5, and if the default has not been remedied within ninety (90) days 30 after the date of notice in writing of the default, IC VA may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
13.3 . In the event that the Licensee LICENSEE becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s 's intention to file an involuntary petition in bankruptcy, the Licensee LICENSEE shall immediately notify IC VA in writing.
13.4 The Licensee . Furthermore, VA shall have the right to terminate this Agreement immediately upon LICENSEE's receipt of written notice. LICENSEE shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC sixty (60) 180 days written notice to that effect.
13.5 IC . VA shall specifically have the right to terminate or modify, at its option, this Agreement, if IC VA determines that the Licensee:
(a) LICENSEE: is not executing the WHO C-TAP Development Plan COMMERCIAL DEVELOPMENT PLAN submitted with its request for a license and the Licensee LICENSEE cannot otherwise demonstrate to IC’s VA’ satisfaction that the Licensee LICENSEE has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application PRACTICAL APPLICATION of the Licensed Products LICENSED PRODUCTS or Licensed Processes;
(b) LICENSED PROCESSES; has not achieved the Benchmarks BENCHMARKS as may be modified under Paragraph 9.2;
(c) ; has willfully made a false statement of, or willfully omitted, omitted a material fact in the license application or in any report required by this the license Agreement;
(d) ; has committed a material breach of a covenant or agreement contained in this
(e) this Agreement; is not keeping Licensed Products LICENSED PRODUCTS or Licensed Processes LICENSED PROCESSES reasonably available to the public after commercial use commences;
(f) ; cannot reasonably satisfy unmet health and safety needs; or
(g) or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 IC VA reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the 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.
13.8 LICENSEE. Within thirty (30) days of receipt of written notice of IC’s VA' unilateral decision to modify or terminate this Agreement, the Licensee LICENSEE may, consistent with the provisions of 37 C.F.R. CFR §404.11, appeal the decision by written submission to the designated IC VA official. The decision of the designated VA official shall be the final agency decision. The Licensee 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 1312, a final report shall be submitted by the LicenseeLICENSEE. 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 IC VA 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 LICENSEE shall return all Licensed Products LICENSED PRODUCTS or other materials MATERIALS included within the Licensed Patent Rights LICENSED PATENT RIGHTS to IC VA or provide IC VA with written certification of the destruction thereof. Neither party may waive or release any of its rights or interests in this Agreement except in writing. The Licensee failure of the GOVERNMENT to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right by the GOVERNMENT or excuse a similar subsequent failure to perform any of these terms or conditions by LICENSEE. This Agreement constitutes the entire agreement between the parties relating to the subject matter of the LICENSED PATENT RIGHTS, LICENSED PRODUCTS and LICENSED PROCESSES, and all prior negotiations, representations, agreements, and understandings are merged into, extinguished by, and completely expressed by this Agreement. The provisions of this Agreement are severable, and in the event that any provision of this Agreement shall be determined to be invalid or unenforceable under any controlling body of law, this determination shall not in any way affect the validity or enforceability of the remaining provisions of this Agreement. If either party desires a modification to this Agreement, the parties shall, upon reasonable notice of the proposed modification by the party desiring the change, confer in good faith to determine the desirability of the modification. No modification shall be effective until a written amendment is signed by the signatories to this Agreement or their designees. The construction, validity, performance, and effect of this Agreement shall be governed by Federal law as applied by the Federal courts in the District of Columbia, United States of America, without giving effect to principles of conflicts of laws. Each of the parties hereby irrevocably submits to the jurisdiction of any federal court sitting in the District of Columbia over any action or proceeding arising out of or relating to this Agreement and each hereby waives the defense of an inconvenient forum for the maintenance of such action.. All Agreement notices required or permitted by this Agreement shall be given by prepaid, first class, registered or certified mail or by an express/overnight delivery service provided by a commercial carrier, properly addressed to the other party at the address designated on the following Signature Page, or to another address as may be designated in writing by the other party. Agreement notices shall be considered timely if the notices are received on or before the established deadline date or sent on or before the deadline date as verifiable by U.S. Postal Service postmark or dated receipt from a commercial carrier. Parties should request a legibly dated U.S. Postal Service postmark or obtain a dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be granted acceptable as proof of timely mailing. This Agreement shall not be assigned by LICENSEE except: with the prior written consent of VA, this consent shall not to be withheld unreasonably; or as part of a sale or transfer of substantially the entire business of LICENSEE relating to operations which concern this Agreement. LICENSEE shall notify VA within ten (10) days of any assignment of this Agreement by LICENSEE, and LICENSEE shall pay VA, as an additional IC licenses royalty, one percent (1%) of the fair market value of any consideration received for any assignment of this Agreement within thirty (30) days of the assignment. LICENSEE agrees in its use of any VA‑supplied MATERIALS to comply with all applicable statutes, regulations, and guidelines, including VA regulations and guidelines. LICENSEE agrees not to use the MATERIALS for research involving human subjects or clinical trials in the United States without complying with 21 CFR Part 50 and 45 CFR Part 46. LICENSEE agrees not to use the MATERIALS for research involving human subjects or clinical trials outside of the United States without notifying VA, in writing, of the research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification to VA of research involving human subjects or clinical trials outside of the United States shall be given no later than sixty (60) days prior to commencement of the research or trials. LICENSEE acknowledges that it is subject to and agrees to abide by the United States laws and regulations (including the Export Administration Act of 1979 and Arms Export Control Act) controlling the export of technical data, computer software, laboratory prototypes, biological material, and other commodities. The transfer of these items may require a license from the appropriate agency of the U.S. Government or written assurances by LICENSEE that it shall not export these items to certain foreign countries without prior approval of this agency. VA neither represents that a license is or is not required or that, if required, it shall be issued. LICENSEE agrees to xxxx the LICENSED PRODUCTS or their packaging sold in the United States with all applicable U.S. patent numbers and similarly to indicate “Patent Pending” status. All LICENSED PRODUCTS manufactured in, shipped to, or sold in other countries shall be marked in a manner to preserve VA patent rights in those countries. By entering into this Agreement, VA does not directly or indirectly endorse any product or service provided, or to be provided, by LICENSEE whether directly or indirectly related to this Agreement. LICENSEE shall not state or imply that this Agreement is an endorsement by the GOVERNMENT, VA, any other GOVERNMENT organizational unit, or any GOVERNMENT employee. Additionally, LICENSEE shall not use the names of VA or the GOVERNMENT or their employees in any advertising, promotional, or sales literature without the prior written approval of VA. The parties agree to attempt to settle amicably any controversy or claim arising under this Agreement or a breach of this Agreement, except for appeals of modifications or termination decisions provided for in Article 13. LICENSEE agrees first to appeal any unsettled claims or controversies to the designated VA official, or designee, whose decision shall be considered the final reporting requirement agency decision. Thereafter, LICENSEE may exercise any administrative or judicial remedies that may be available. Nothing relating to the grant of a license, nor the grant itself, shall be construed to confer upon any person any immunity from or defenses under the antitrust laws or from a charge of patent misuse, and the acquisition and use of rights pursuant to 37 CFR Part 404 shall not be immunized from the operation of state or Federal law by reason of the source of the grant. Any formal recordation of this Agreement required by the laws of any LICENSED TERRITORY as a prerequisite to enforceability of the Agreement in the courts of any foreign jurisdiction or for other reasons will be carried out by LICENSEE at its expense, and appropriately verified proof of recordation will be promptly furnished to VA. Paragraph 4.3, 8.1, 9.5-9.7, 11.1-11.5, 12.9, 12.10, and 13.13 of this Agreement shall survive termination of this Agreement. The terms and conditions of this Agreement shall, at VA’ sole option, be considered by VA 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 not fulfilledexecuted by the LICENSEE and a fully executed original is received by VA within sixty (60) days from the date of VA signature found at the Signature Page. For VA: ____________________________________ _______________ Date Xxxx X. Xxxxxx, PhD, JD, PE Director, Technology Transfer ____________________________________ _______________ Date Xxxxx X. Xxxxx General Counsel Mailing Address for Agreement notices: Director, Technology Transfer Department of Veterans Affairs (10PTT) 000 Xxxxxxx Xxx, XX Xxxxxxxxxx, XX 00000 X.X.X. For LICENSEE (Upon, information and belief, the undersigned expressly certifies or affirms that the contents of any statements of LICENSEE made or referred to in this document are truthful and accurate.): by: ____________ DRAFT ________________________ _______________ Signature of Authorized Official Date Printed Name Title Official and Mailing Address for Agreement notices: Official and Mailing Address for Financial notices (LICENSEE’s contact person for royalty payments) Name Title Mailing Address: Email Address: Phone: Fax: Any false or misleading statements made, presented, or submitted to the GOVERNMENT, including any relevant omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§3801-3812 (civil liability) and 18 U.S.C. §1001 (criminal liability including fine(s) or imprisonment).
Appears in 1 contract
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC 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 by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
13.3 In the event that the Licensee (i) becomes insolvent, (ii) files a petition in bankruptcy, or has such a petition filed against itit and, determines to file a in either case, such petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcyis not dismissed within sixty (60) days, the Licensee shall immediately notify IC the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:: NIH 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 WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved 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, 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 thisthis Agreement;
(e) is not keeping the Licensed Products or the Licensed Processes within the scope of the Licensed Fields of Use reasonably available 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, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s reasonable concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s reasonable satisfaction, IC the NIH may terminate this Agreement.
13.7 IC 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 the 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
13.8 13.9 Within thirty (30) days of receipt of written notice of IC’s 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 IC 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 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 expenseexpenses, due to IC 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 IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC NIH licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License Agreement (Lion Biotechnologies, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 . In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC the NIH in writing.
13.4 . The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC . The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:
(a) : is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) ; has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) ; has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement;
(d) ; has committed a material breach of a covenant or agreement contained in this
(e) this Agreement; 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) or 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s satisfaction, IC the NIH may terminate this Agreement.
13.7 IC . 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 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 ICthe 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 IC the NIH official. The decision of the designated the 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 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 IC the NIH 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 IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC NIH licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights Rights, or twenty (20) years, whichever is longer, U.S. Orphan Drug Exclusivity unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) [***] days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 or any licenses in any country or territory by giving the IC sixty (60) [***] days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis 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, 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(h13.5(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(h13.5(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 the 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.
13.8 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 officialofficial 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 availableaccessible.
13.9 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 expenseexpenses, 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
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement AGREEMENT is effective when signed by all parties, unless on the provisions of Paragraph 14.15 are not fulfilled, EFFECTIVE DATE and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, LICENSED PATENT RIGHTS unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this AgreementAGREEMENT, including but not limited to the obligations listed in Paragraph 13.5Article 13.05, and if the default has not been remedied remedied, within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement AGREEMENT by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Actnotice.
13.3 13.03 In the event that the Licensee LICENSEE becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s 's intention to file an involuntary petition in bankruptcy, the Licensee LICENSEE shall immediately notify IC PHS in writing.
13.4 The Licensee 13.04 LICENSEE shall have a unilateral right to terminate this Agreement AGREEMENT and/or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.05 PHS shall specifically have the right to terminate or modify, at its option, this AgreementAGREEMENT, if IC PHS determines that the Licensee:
(aLICENSEE: 1) is not executing the WHO C-TAP Development Plan COMMERCIAL DEVELOPMENT PLAN submitted with its request for a license license, as amended or modified at the pertinent time, and the Licensee LICENSEE cannot otherwise demonstrate to IC’s PHS'S satisfaction that the Licensee LICENSEE has taken, taken or can be expected to take within a reasonable time, effective steps to achieve Practical Application practical application of the Licensed Products LICENSED PRODUCTS or Licensed Processes;
(bLICENSED PROCESSES; 2) has not achieved the Benchmarks Benchmarks, as may be amended or modified under Paragraph 9.2;
(cat 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 this Agreement;
(dthe license agreement; 4) has committed a material breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products LICENSED PRODUCTS or Licensed Processes LICENSED PROCESSES reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety needs; or
(gor 7) 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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.5.02
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC 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 by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
13.3 In the event that the Licensee (i) becomes insolvent, (ii) files a petition in bankruptcy, or has such a petition filed against itit and, determines to file a in either case, such petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcyis not dismissed within sixty (60) days, the Licensee shall immediately notify IC the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:: NIH 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 WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved 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, 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 thisthis Agreement;
(e) is not keeping the Licensed Products or the Licensed Processes within the scope of the Licensed Fields of Use reasonably available 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, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s reasonable concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s reasonable satisfaction, IC the NIH may terminate this Agreement.
13.7 IC 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 the 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
13.8 13.9 Within thirty (30) days of receipt of written notice of IC’s 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 IC 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 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 expenseexpenses, due to IC 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 IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC NIH licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License Agreement (Lion Biotechnologies, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC 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 by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
13.3 In the event that the Licensee (i) becomes insolvent, (ii) files a petition in bankruptcy, or has such a petition filed against itit and, determines to file a in either case, such petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcyis not dismissed within sixty (60) days, the Licensee shall immediately notify IC the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:: 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 WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved 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, 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 thisthis Agreement;
(e) is not keeping the Licensed Products or the Licensed Processes within the scope of the Licensed Fields of Use reasonably available 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, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s reasonable concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s reasonable satisfaction, IC the NIH may terminate this Agreement.
13.7 IC 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 the 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
13.8 13.9 Within thirty (30) days of receipt of written notice of IC’s 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 IC 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 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 expenseexpenses, due to IC 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 IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC NIH licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License Agreement (Lion Biotechnologies, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when 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 all the authorized representatives of the parties, unless in accordance to the provisions of Paragraph 14.15 are 14.16. Upon fulfillment of all conditions under this paragraph 13.1(a-c), this Agreement is effective on the Effective Date.
13.2 This Agreement shall take effect on the Effective Date and shall expire (unless sooner terminated as provided in this Article 13) either:
(a) Thirty-six (36) months from the Effective Date, if not fulfilledextended 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 shall extend to either (ii) provided IC written evidence of commercially reasonable progress toward Licensee-sponsored clinical studies of a Licensed Product and adherence with the expiration Commercial Development Plan, (such evidence may include, but is not limited to, completed experiments showing non-clinical pharmacology or toxicology data, and any completed regulatory filings) on the date of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13Rights.
13.2 13.3 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
13.3 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.
13.4 13.5 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.. CONFIDENTIALNIH Patent License Agreement--ExclusiveModel 10-2015 Page 15 of 33 [Final] [Connectyx] [January 2021]
13.5 13.6 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis 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, 5.2 unless waived; 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 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(h13.5(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(h13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement.
13.7 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 reserves shall have 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 IC’s unilateral decision to modify or terminate this Agreement, require the Licensee mayto grant sublicenses to responsible applicants, consistent with the provisions on reasonable terms, in any Licensed Fields of 37 C.F.R. §404.11, appeal the decision by written submission to the designated IC official. The decision of the designated 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 Use 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide IC with written certification Rights, unless the Licensee can reasonably demonstrate that the granting of the destruction thereof. The Licensee may sublicense would not be granted additional IC licenses if materially increase the final reporting requirement is not fulfilled.availability to the public of the subject matter of the
Appears in 1 contract
Samples: Patent License Agreement (Curative Biotechnology Inc)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 '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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.. A-035-2017 NIH Patent License Agreement--Exclusive Model 10-2015 [Final] [Selecta Biosciences] [3 April 2017]
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) a. is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) b. has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) c. has willfully made a false statement of, or willfully omitted, omitted a material fact in the license application or in any report required by this Agreement;
(d) d. has committed a material breach of a covenant or agreement contained in thisthis Agreement;
(e) e. is not keeping the Licensed Products or the Licensed Processes reasonably available to the public after commercial use commences;
(f) f. cannot reasonably satisfy unmet health and safety needs; or
(g) g. cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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(h13.5(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(h13.5(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 the 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.
13.8 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 officialofficial 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.accessible. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. A-035-2017 NIH Patent License Agreement--Exclusive Model 10-2015 [Final] [Selecta Biosciences] [3 April 2017]
13.9 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 expenseexpenses, 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
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days [***] after the date of notice in writing of the default, IC the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any Licensed Fields of Use in any country or territory by giving IC sixty (60) days the NIH [***] written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this AgreementAgreement by written notice to the Licensee, if IC the NIH reasonably determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the 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, 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 thisthis 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; or;
(g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day [***] opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or within [***] following written notice from the NIH or otherwise fails to initiate corrective action to ICthe NIH’s satisfaction, IC the NIH may terminate this AgreementAgreement upon written notice to the Licensee.
13.7 IC 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 the 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 LicenseeLicensee within [***] following written notice from the NIH.
13.8 13.9 Within thirty (30) days [***] of receipt of written notice of IC’s 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 IC 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 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 expenseexpenses, due to IC 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 have the right to offer for sale and sell any existing inventory of Licensed Products or other materials included within for a period of [***] following the Licensed Patent Rights effective termination date of this Agreement, subject to IC or provide IC with written certification of the destruction thereof. royalty obligations as set forth in Appendix C. The Licensee may not be granted additional IC 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. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend extend, on a Licensed Product-by-Licensed Product (or Licensed Process-by-Licensed Process) and country-by-country basis, to either the expiration of the last to expire of the Licensed Patent Rights that claims such Licensed Product (or twenty (20Licensed Process) years, whichever is longer, in such country unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 partyThird 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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC reasonably determines that the Licensee:: [***] CONFIDENTIAL NIH Patent License Agreement--Exclusive Model 10-
(a) is not executing using commercially reasonable efforts to execute the WHO C-TAP Commercial Development Plan submitted with its request for a license license, as may be amended pursuant to Paragraph 9.2, and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved 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, 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 thisthis 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, 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(hParagraph 13.5(a)-13.5(g). If the Licensee fails to reasonably alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(hParagraph 13.5(a)-13.5(g) or fails to initiate 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 IC reserves the right according Agreement upon written notice 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 IC’s unilateral decision 13.7 When the public health and safety so require, and after providing the Licensee a [***] opportunity to modify or terminate this Agreementrespond, 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, have the right to require the Licensee shall return all to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Products or other materials included within Fields of Use under the Licensed Patent Rights to IC or provide IC with written certification Rights, unless the Licensee can reasonably demonstrate that the granting of the destruction thereof. The Licensee may sublicense would not be granted additional IC licenses if materially increase the final reporting requirement is not fulfilled.availability to the public of the subject matter of the
Appears in 1 contract
Samples: Patent License Agreement (Dynamics Special Purpose Corp.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement;
(d) has committed a material breach of a covenant or agreement contained in thisthis 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; 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 . ***Redacted***CONFIDENTIAL PHS Patent License Agreement.—Nonexclusive_Sublicense
13.6 In making the determination referenced in Paragraph 13.5, IC PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC PHS shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to IC’s PHS’ satisfaction, IC PHS may terminate this Agreement.
13.7 IC PHS 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 IC’s PHS’ 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 PHS official. The decision of the designated PHS 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 IC PHS 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 PHS 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 IC PHS or provide IC PHS with written certification of the destruction thereof. The Licensee may not be granted additional IC PHS licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Actnotice.
13.3 13.03 At least thirty (30) days prior to filing a petition in bankruptcy, Licensee must inform PHS in writing of its intention to file the petition in bankruptcy or of a third party's intention to file an involuntary petition in bankruptcy.
13.04 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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement by giving Licensee written notice. Termination of this Agreement is effective upon Licensee's receipt of the written notice.
13.4 The 13.05 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC PHS sixty (60) days days' written notice to that effect.
13.5 IC 13.06 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: 1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS's satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application practical application of the Licensed Products or Licensed Processes;
(b; 2) 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; 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 Agreement9.
13.6 In making the determination referenced in Paragraph 13.5, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
Samples: Patent License Agreement (Targeted Genetics Corp /Wa/)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days [***] after the date of notice in writing of the default, IC the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any Licensed Fields of Use in any country or territory by giving IC sixty (60) days the NIH [***] written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this AgreementAgreement by written notice to the Licensee, if IC the NIH reasonably determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis 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; or;
(g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day [***] opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or within [***] following written notice from the NIH or otherwise fails to initiate corrective action to ICthe NIH’s satisfaction, IC the NIH may terminate this AgreementAgreement upon written notice to the Licensee.
13.7 IC 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 the 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 LicenseeLicensee within [***] following written notice from the NIH.
13.8 13.9 Within thirty (30) days [***] of receipt of written notice of IC’s 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 IC 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 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 expenseexpenses, due to IC 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 have the right to offer for sale and sell any existing inventory of Licensed Products or other materials included within for a period of [***] following the Licensed Patent Rights effective termination date of this Agreement, subject to IC or provide IC with written certification of the destruction thereof. royalty obligations as set forth in Appendix C. The Licensee may not be granted additional IC 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. 13.1 13.01 This Agreement AGREEMENT is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, LICENSED PATENT RIGHTS unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee LICENSEE is in default in the performance of any material obligations under this AgreementAGREEMENT, including but not limited to the obligations listed in Paragraph 13.5Article 13.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement AGREEMENT by written notice and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.
13.3 13.03 In the event that the Licensee 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 LICENSEE shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this AGREEMENT immediately upon LICENSEE’S receipt of written notice.
13.4 The Licensee 13.04 LICENSEE shall have a unilateral right to terminate this Agreement AGREEMENT and/or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.05 PHS shall specifically have the right to terminate or modify, at its option, this AgreementAGREEMENT, if IC PHS determines that the Licensee:
(aLICENSEE: 1) is not executing the WHO C-TAP Development Plan COMMERCIAL DEVELOPMENT PLAN submitted with its request for a license and the Licensee LICENSEE cannot otherwise demonstrate to ICPHS’s satisfaction that the Licensee LICENSEE has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application PRACTICAL APPLICATION of the Licensed Products LICENSED PRODUCTS or Licensed Processes;
(bLICENSED PROCESSES; 2) has not achieved the Benchmarks BENCHMARKS as may be modified under Paragraph 9.2;
(c9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement;
(dthe license AGREEMENT; 4) has committed a material breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products LICENSED PRODUCTS or Licensed Processes LICENSED PROCESSES reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety needs; or
(gor 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.02 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 13.5this determination, IC shall 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 the Licensee LICENSEE under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement9.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.513.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.
13.3 13.03 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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The 13.04 Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.05 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: 1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICPHS’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products Drug or Licensed Processes;
(bProcess(es); 2) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this the license Agreement;
(d; 4) has committed a material breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products Drug or Licensed Processes Process(es) reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety needs; or
(gor 7) 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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.5.02
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5Article 13.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.
13.3 13.03 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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee's receipt of written notice pursuant to this Paragraph 13.03.
13.4 The 13.04 Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.05 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: 1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS's satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;that
(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; 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, 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 9.202. Prior to invoking termination or modification of this Agreement under Paragraph 13.5right, IC PHS shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s PHS's concerns as to the previous items referenced in 13.5(a)-13.5(h1) to 7). If the Licensee fails to alleviate IC’s PHS's concerns as to the previous items referenced in 13.5(a)-13.5(h1) to 7) or fails to initiate corrective action to IC’s PHS's satisfaction, IC PHS may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
Samples: Patent License Agreement (Seattle Genetics Inc /Wa)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 '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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 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, 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(h13.5(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(h13.5(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 the 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.
13.8 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 officialofficial 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 availableaccessible.
13.9 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 expenseexpenses, 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
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 12.1 This Agreement is shall become effective when signed by all parties, as of the Effective Date unless the provisions of Paragraph 14.15 22 are not fulfilled, fulfilled and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty twenty-four (2024) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving IC months from its Effective Date. Within sixty (60) days written notice to that effect.
13.5 IC shall specifically have of the right to terminate termination or modify, at its option, expiration of this Agreement, if unless an IC determines 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 5.3 of this Agreement, the Licensee shall return all Materials and Licensed Products to the IC or provide the IC with written certification of their destruction. The Licensee further agrees that it shall be responsible for the destruction of any remaining Materials and Licensed Products from the Third Party Collaborator(s) and Third Party Contractor(s) to the Licensee:
(a) is not executing the WHO C-TAP Development Plan submitted with its request for a license , and the Licensee cannot otherwise demonstrate shall obtain written certification from the Third Party Collaborator(s) and Third Party Contractor(s) that any remaining Materials or Licensed Products in their possession have been destroyed and to IC’s satisfaction that the Licensee has taken, or can be expected to take provide IC with a copy of said written notification within a reasonable time, effective steps to achieve Practical Application sixty (60) days of the Licensed Products termination 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 expiration 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; 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 12.2 The IC reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined determines that the 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.
13.8 12.3 The IC shall specifically have the right to terminate or modify this Agreement, at its sole option, if the IC determines that the Licensee: has not adhered to the Commercial Evaluation Plan in Appendix E, as may be amended by mutual agreement of the parties; 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; has willfully made a false statement 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; or cannot reasonably satisfy unmet health and safety needs.
12.4 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 officialofficial 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 availableaccessible.
13.9 12.5 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
12.6 Within ninety thirty (9030) days of expiration or termination of this Agreement under this Article 1312, a final written report shall be submitted by the LicenseeLicensee in accordance with Paragraph 11.
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 (such as the full minimum annual royalty)paid, and those related to patent expenseexpenses, due to the IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Actnotice.
13.3 13.03 At least thirty (30) days prior to filing a petition in bankruptcy, Licensee must inform PHS in writing of its intention to file the petition in bankruptcy or of a third party's intention to file an involuntary petition in bankruptcy.
13.04 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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement by giving Licensee written notice. Termination of this Agreement is effective upon Licensee's receipt of the written notice.
13.4 The 13.05 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC PHS sixty (60) days days' written notice to that effect.
13.5 IC 13.06 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: 1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS's satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application practical application of the Licensed Products or Licensed Processes;
(b) ; 2} 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; 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 Agreement9.
13.6 In making the determination referenced in Paragraph 13.5, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
Samples: Patent License Agreement (Advanced Life Sciences Holdings, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC 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 by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
13.3 In the event that the Licensee (i) becomes insolvent, (ii) files a petition in bankruptcy, or has such a petition filed against itit and, determines to file a in either case, such petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcyis not dismissed within sixty (60) days, the Licensee shall immediately notify IC the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:: CONFIDENTIAL 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 WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved 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, 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 thisthis Agreement;
(e) is not keeping the Licensed Products or the Licensed Processes within the scope of the Licensed Fields of Use reasonably available 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, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s reasonable concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s reasonable satisfaction, IC the NIH may terminate this Agreement.
13.7 IC 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 the 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
13.8 13.9 Within thirty (30) days of receipt of written notice of IC’s 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 IC 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 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 expenseexpenses, due to IC 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 IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC NIH licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either 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 Jointly Owned Licensed Patent Rights or twenty (20) years, whichever is longer, in such country in the Licensed Territory unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 partyThird 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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, modify this Agreement, if the IC determines that the Licensee:Licensee (and its Affiliates and Sublicensees):
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license license, and the Licensee cannot otherwise demonstrate to the IC’s reasonable satisfaction that the 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 thisthis 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; 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.
13.6 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 initiate 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 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 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 officialofficial 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), and those related to patent expense, that are due to the IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for If terminated under this AgreementArticle 13, upon termination of this Agreement, Sublicensees may elect to convert their sublicenses to direct licenses with the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights IC pursuant to IC or provide IC with written certification of the destruction thereofParagraph 4.3. The Licensee may not be granted additional IC licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License Agreement (Lixte Biotechnology Holdings, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee ATHENA is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC WU may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Actnotice.
13.3 13.03 At least thirty (30) days prior to filing a petition in bankruptcy, ATHENA must inform WU in writing of its intention to file the petition in bankruptcy or of a third party's intention to file an involuntary petition in bankruptcy.
13.04 In the event that the Licensee ATHENA becomes insolvent, files a petition in bankruptcybankruiptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s 's intention to file an involuntary petition in bankruptcy, the Licensee ATHENA shall immediately notify IC WU in writing. Furthermore, WU shall have the right to terminate this Agreement by giving ATHENA written notice. Termination of this Agreement is effective upon ATHENA's receipt of the written notice.
13.4 The Licensee 13.05 ATHENA shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC WU sixty (60) days days' written notice to that effect.
13.5 IC 13.06 WU shall specifically have the right to terminate or modifyrender non-exclusive, at its option, this Agreement, if IC WU determines that the Licensee:
ATHENA: (a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee ATHENA cannot otherwise demonstrate to IC’s WU's satisfaction that the Licensee ATHENA has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application practical application of the Licensed Products or Licensed Processes;
; (b) has not achieved been reasonably diligent in its pursuit of the Benchmarks as may be modified under Paragraph 9.2;
milestones in the Product Plan; (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;
the license agreement; (d) has committed a material substantial breach of a covenant or agreement contained in this
the license; (e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
; or, (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.
13.6 In making the determination referenced in Paragraph 13.5, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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.Section 5.02
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 partyThird 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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, omitted a material fact in the license application or in any report required by this Agreement;
; CONFIDENTIAL NIH Patent License Agreement–Exclusive US-DOCS\144314366.1 17 (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; 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
Samples: Patent License Agreement (CARGO Therapeutics, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) [***] days after the date of notice in writing of the default, IC Leidos Biomedical may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.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 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 IC Leidos Biomedical in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC sixty (60) Leidos Biomedical [***] days written notice to that effect.,
13.5 IC Leidos Biomedical shall specifically have the right to terminate or modifymodify (subject to Licensee’s agreement to such modification), at its option, this Agreement, using the process set forth in Section 13.2, if IC Leidos Biomedical determines that the Licensee:;
(a) is not executing using commercially reasonable efforts to execute the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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; 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 13.5Xxxxxxxxx 00.0, IC Xxxxxx 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. 9,2, Prior to invoking termination or modification of this Agreement under Paragraph 13.5Xxxxxxxxx 00.0, IC Xxxxxx Biomedical shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) [***] day opportunity to respond to, ICLeidos Biomedical’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICLeidos Biomedical’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICLeidos Biomedical’s satisfaction, IC Leidos Biomedical may terminate this Agreement.
13.7 IC reserves 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 according to 35 U.S.C. §209(d)(3) require the Licensee to terminate or modify this Agreement if it is determined 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 action is necessary to meet the requirements for public use specified by federal regulations issued after the date granting of the license and these requirements are sublicense would not reasonably satisfied by 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 thirty (30) days of receipt of written notice of 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. The decision of the designated 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 expenseexpenses, due to IC 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 IC Leidos Biomedical or provide IC Leidos Biomedical with written certification of the destruction thereof. The Licensee may not be granted additional IC Leidos Biomedical licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 partyThird 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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;; CONFIDENTIAL NIH Patent License Agreement–Exclusive US-DOCS\144314993.1 19
(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, 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 thisthis 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, 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 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 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 the 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.. CONFIDENTIAL NIH Patent License Agreement–Exclusive US-DOCS\144314993.1 20
13.8 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 officialofficial 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 availableaccessible.
13.9 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 expenseexpenses, 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
Samples: Patent License Agreement (CARGO Therapeutics, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5Article 13.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.
13.3 13.03 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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee's receipt of written notice.
13.4 The 13.04 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.05 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: I) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS's satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this the license Agreement;
(d; 4) has committed a material breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety needs; or
(gor 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.02 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 13.5this determination, IC shall PHS will take into account the normal course of such commercial development programs conducted with sound and reasonable reason able 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement9.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
Samples: Exclusive License Agreement (Cyplasin Biomedical Ltd.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 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, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s satisfaction, IC the NIH may terminate this Agreement.
13.7 IC When the public health and safety so require, and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, the NIH shall have the right to require the Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless the Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. The NIH shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee.
13.8 The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the 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.
13.8 13.9 Within thirty (30) days of receipt of written notice of IC’s 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 IC 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 availableaccessible.
13.9 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 expenseexpenses, due to IC 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 IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC NIH licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 Agreement contained in thisthis 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, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s satisfaction, IC the NIH may terminate this Agreement.
13.7 IC When the public health and safety so require, and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, the NIH shall have the right to require the Licensee to grant sublicenses to responsible applicants, on reasonable terms. in any Licensed Fields of Use under the Licensed Patent Rights, unless the Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. The NIH shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee.
13.8 The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the 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.
13.8 13.9 Within thirty (30) days of receipt of written notice of ICthe 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 IC the NIH official. The decision of the designated the 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 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 IC 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 IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC the N III licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Start Up Patent License Agreement (Medicenna Therapeutics Corp.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days [***] after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 in any country or territory by giving the IC sixty (60) days [***] written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not using reasonable commercial efforts, as defined in Paragraph 10.1, in executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve 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 thisthis 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; 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(h13.5(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(h13.5(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 If terminated under this AgreementArticle 13, upon sublicensees may elect to convert their sublicenses to direct licenses with the IC pursuant to Paragraph 4.3. For a period of [***] following termination or expiration of this Agreement, the Licensee shall have the right to offer for sale and sell any existing inventory of Licensed Products, subject to the royalty obligations as set forth in Appendix C. After this [***] period, the Licensee shall return all remaining Licensed Products or other materials included within the Licensed Patent Rights to the 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
Samples: Patent License Agreement (Cellular Biomedicine Group, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.513.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice notice, and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.
13.3 13.03 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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The 13.04 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.05 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: 1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICPHS’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application practical application of the Licensed Products or Licensed Processes;
(b; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement;
(dthe license agreement; 4) has committed a material breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety needs; or
(gor 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.02 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 13.5this determination, IC shall 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 the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement9.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective as of 1 August 2017 when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:: NIH Patent License Agreement--Exclusive
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis 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, 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(h13.5(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(h13.5(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 the 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.
13.8 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 officialofficial 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.accessible. NIH Patent License Agreement--Exclusive
13.9 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 expenseexpenses, 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
Samples: Patent License Agreement (Atlantic Coastal Acquisition Corp. II)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when (“Effective Date”)when signed by all parties, unless the provisions of Paragraph 14.15 14.17 are not fulfilled, and shall extend to either the expiration or termination of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in material default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days [*] after the date of notice in writing of the default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC sixty (60) days PHS [*] written notice to that effect.
13.5 IC Subject to Paragraph 13.5, PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, omitted a material fact in the license application or in any report required by this the license Agreement;
(d) has committed a material breach of a material covenant or material agreement contained in thisthis Agreement;
(e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f) cannot reasonably not, after First Commercial Sale, reasonable satisfy unmet health and safety needs; oror [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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, IC PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC PHS shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to IC’s PHS’ satisfaction, IC PHS, subject to Paragraph 13.8, may modify or terminate this Agreement.
13.7 IC When the public health and safety so require, and after written notice to Licensee providing Licensee a sixty (60) day opportunity to respond, PHS shall have the right to require Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless 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. PHS shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with Licensee.
13.8 Subject to Paragraph 13.8, PHS reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the 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.
13.8 13.9 Within thirty (30) days of receipt of written notice of IC’s PHS’ unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. CFR §404.11, appeal the decision by written submission to the designated IC PHS official. The decision of the designated PHS 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 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 IC PHS 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 PHS 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 IC PHS or provide IC PHS with written certification of the destruction thereof. The Licensee may not be granted additional IC licenses if [*] = Certain confidential information contained in this document, marked by brackets, is filed with the final reporting requirement is not fulfilledSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless as of the provisions of Paragraph 14.15 are not fulfilled, Effective Date and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, the royalty term defined in Section 6.03.3 unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee LICENSEE is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC OHSU may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Actnotice.
13.3 13.03 In the event that the Licensee 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 LICENSEE shall immediately notify IC OHSU in writing. Furthermore, OHSU shall have the right to terminate this Agreement by giving LICENSEE written notice. Termination of this Agreement is effective upon LICENSEE’s receipt of the written notice.
13.4 The Licensee 13.04 LICENSEE shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC OHSU sixty (60) days written notice to that effect.
13.5 IC 13.05 OHSU shall specifically have the right to terminate or modify, at its option, this Agreement, Agreement if IC determines that the Licensee:
LICENSEE (a) is not executing the WHO C-TAP Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICOHSU’s satisfaction that the Licensee LICENSEE has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application practical application of the Licensed Products, Screening Products or Licensed Processes;
Processes under Article 9; (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;
the license agreement; or (dc) has committed a material substantial 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; 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 Agreementlicense.
13.6 In making the determination referenced in Paragraph 13.5, 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 9.201. Prior to invoking termination or modification of this Agreement under Paragraph 13.5right, IC OHSU shall give written notice to the Licensee LICENSEE providing the Licensee LICENSEE specific notice of, and a ninety (90) day opportunity to respond to, ICOHSU’s concerns as to the previous items referenced in 13.5(a)-13.5(h(a) to (c). If the Licensee LICENSEE fails to alleviate ICOHSU’s concerns as to the previous items referenced in 13.5(a)-13.5(h(a) to (c) or fails to initiate corrective action to ICOHSU’s satisfaction, IC OHSU may terminate this Agreement.
13.7 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 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. The decision of the designated 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 13.06 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by the LicenseeLICENSEE. Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expenseexpenses, due to IC OHSU shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for If terminated under this AgreementArticle 13, upon sublicensees may elect to convert their sublicenses to direct licenses with OHSU pursuant to Paragraph 4.03.
13.07 Upon termination of this Agreement, the Licensee shall return LICENSEE shall, at its own expense, forthwith remove, efface or destroy all Licensed Products references to OHSU from all advertising or other materials included within used in the promotion of LICENSEE’s business or sublicensees and LICENSEE or sublicensees shall not thereafter represent in any manner that it has rights in or to the Patent Rights, Licensed Patent Rights Products, Screening Products, or Licensed Processes.
13.08 Immediately upon termination, LICENSEE agrees to IC return all MICE to OHSU, or provide IC with written certification to destroy said MICE and certify in writing to OHSU that MICE have been destroyed.
13.09 Paragraphs 4.03, 7.01, 8.04, 12.01-12.05, and 14.11 of the destruction thereof. The Licensee may not be granted additional IC licenses if the final reporting requirement is not fulfilledthis Agreement shall survive termination of this Agreement.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5Article 13.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties amounts owed through procedures provided by the Federal Debt Collection Act.
13.3 13.03 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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee's receipt of written notice.
13.4 The 13.04 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC 13.05 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: 1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS's satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b; 2) 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; 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 Agreement9.
13.6 In making the determination referenced in Paragraph 13.5, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is shall become effective when signed by all parties, as of the Effective Date unless the provisions of Paragraph 14.15 14.16 are not fulfilled, fulfilled and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty twenty-four (2024) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving IC months from its Effective Date. Within sixty (60) days written notice to that effect.
13.5 IC shall specifically have of the right to terminate termination or modify, at its option, expiration of this Agreement, if unless an IC determines 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 IC or provide the IC with written certification of their destruction. The Licensee further agrees that it shall be responsible for the destruction of any remaining Materials and Licensed Products from the Third Party Contractor(s) to the Licensee:
(a) is not executing the WHO C-TAP Development Plan submitted with its request for a license , and the Licensee cannot otherwise demonstrate shall obtain written certification from the Third Party Contractor(s) that any remaining Materials or Licensed Products in their possession have been destroyed and to IC’s satisfaction that the Licensee has taken, or can be expected to take provide IC with a copy of said written notification within a reasonable time, effective steps to achieve Practical Application sixty (60) days of the Licensed Products termination 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 expiration 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; 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 13.2 The IC reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined determines that the 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.
13.8 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 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 officialofficial 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 availableaccessible.
13.9 13.5 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect. NIH Patent License Agreement--Exclusive Model 10-2015 Page 11 of 24 [Draft2] [Connectyx] [2020 September]
13.6 Within ninety thirty (9030) days of expiration or termination of this Agreement under this Article 13, a final written report shall be submitted by the LicenseeLicensee in accordance with Paragraph 9.
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 (such as the full minimum annual royalty)paid, and those related to patent expenseexpenses, due to the IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
Samples: Patent License Agreement (Curative Biotechnology Inc)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.17 are not fulfilled, and shall extend to either the expiration of the last to expire of Valid Claim within the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days [***] after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 partyThird Party’s intention to file an involuntary petition in bankruptcy, the Licensee shall immediately promptly notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving the IC sixty (60) days [***] written notice to that effect.
13.5 The IC shall specifically have the right to terminate this Agreement pursuant to Paragraph 13.6, such termination to be deemed effective upon the earliest of: 1. expiration of the [***] time period by which Licensee can submit a formal written appeal, if such period expires without submission by Licensee of such appeal, 2. upon final agency decision in response to the formal written appeal in accordance with Paragraph 13.9, or modify, at 3. upon Licensee’s written notification of its option, acceptance of the termination of this Agreement, if the IC reasonably determines that the Licensee:
(a) is not executing using reasonable commercial efforts to execute the WHO C-TAP Commercial Development Plan submitted with its request for a license (as amended in accordance with this Agreement) and the Licensee cannot otherwise demonstrate to the IC’s reasonable satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective reasonable commercial 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, 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 thisthis 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; or
(h) 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(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 satisfactionreasonable satisfaction within such [***] period, the IC may terminate this AgreementAgreement upon written notice to 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 IC reserves shall have 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 IC’s unilateral decision to modify or terminate this Agreement, require the Licensee mayto grant sublicenses to responsible applicants, consistent with the provisions on reasonable terms, in any Licensed Fields of 37 C.F.R. §404.11, appeal the decision by written submission to the designated IC official. The decision of the designated 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 Use 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide IC with written certification Rights, unless the Licensee can reasonably demonstrate that the granting of the destruction thereof. The Licensee may sublicense would not be granted additional IC licenses if alleviate concerns of public health and safety and materially increase the final reporting requirement is not fulfilled.availability to the public of the subject matter of the
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve 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; 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(h13.5(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(h13.5(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. 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
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 12.01 This Agreement AGREEMENT is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, LICENSED PATENT RIGHTS unless sooner terminated as provided in this Article 1312.
13.2 12.02 In the event that the Licensee LICENSEE is in default in the performance of any material obligations under this AgreementAGREEMENT, including but not limited to the obligations listed in Paragraph 13.5Article 12.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PDM may terminate this Agreement AGREEMENT by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Actnotice.
13.3 12.03 In the event that the Licensee LICENSEE becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s 's intention to file an involuntary petition in bankruptcy, the Licensee LICENSEE shall immediately notify IC PDM in writing.
13.4 The Licensee 12.04 LICENSEE shall have a unilateral right to terminate this Agreement AGREEMENT and/or any licenses in any country or territory by giving IC PDM sixty (60) days written notice to that effect.
13.5 IC 12.05 PDM shall specifically have the right to terminate or modify, at its option, this AgreementAGREEMENT, if IC PDM determines that the Licensee:
(aLICENSEE: 1) is not executing the WHO C-TAP Development Plan COMMERCIAL DEVELOPMENT PLAN submitted with its request for a license and the Licensee LICENSEE cannot otherwise demonstrate to IC’s PDM's satisfaction that the Licensee LICENSEE has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application practical application of the Licensed Products LICENSED PRODUCTS or Licensed LICENSED Processes;
(b; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c8.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement;
(dthe license agreement; 4) 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; 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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.agreement
Appears in 1 contract
Samples: Patent License Agreement (Utek Corp)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Actnotice.
13.3 13.03 At least thirty (30) days prior to fling a petition in bankruptcy, Licensee must inform PHS in writing of its intention to file the petition in bankruptcy or of a third party’s intention to file an involuntary petition in bankruptcy.
13.04 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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement by giving Licensee written notice. Termination of this Agreement is effective upon Licensee’s receipt of the written notice.
13.4 The 13.05 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC PHS sixty (60) days days’ written notice to that effect.
13.5 IC 13.06 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: 1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICPHS’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application practical application of the Licensed Products or Licensed Processes;
(b; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement;
(dthe license agreement; 4) has committed a material substantial breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety safely needs; or
(gor 7) 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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.5.01
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC PHS sixty (60) days written notice to that effect.
13.5 IC PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis 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, 5.2 unless waived; or
. PHS Patent License Agreement–Exclusive Model 10-2005 (hupdated 8-2010) has been found by a court Page 12 of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement.25 Oculus Innovative Sciences, Inc. Date Printed: August 17, 2011
13.6 In making the determination referenced in Paragraph 13.5, IC PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC PHS shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to IC’s PHS’ satisfaction, IC PHS may terminate this Agreement.
13.7 IC When the public health and safety so require, and after written notice to Licensee providing Licensee a sixty (60) day opportunity to respond, PHS shall have the right to require Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless 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. PHS shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with Licensee.
13.8 PHS reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the 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.
13.8 13.9 Within thirty (30) days of receipt of written notice of IC’s PHS’ 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 PHS official. The decision of the designated PHS 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 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 IC PHS 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 PHS 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 IC PHS or provide IC PHS with written certification of the destruction thereof. The Licensee may not be granted additional IC PHS licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License Agreement (Oculus Innovative Sciences, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve 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; 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(h13.5(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(h13.5(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
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement;
(d) has committed a material breach of a covenant or agreement contained in this
(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; 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s satisfaction, IC the NIH may terminate this Agreement.
13.7 IC 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 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 ICthe 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 IC the NIH official. The decision of the designated the 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 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 IC the NIH 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 IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC NIH licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend extend, on a Licensed Product-by-Licensed Product (or Licensed Process-by-Licensed Process) and country-by-country basis, to either the expiration of the last to expire of the Licensed Patent Rights that claims such Licensed Product (or twenty (20Licensed Process) years, whichever is longer, in such country unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 partyThird 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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC reasonably determines that the Licensee:
(a) is not executing using commercially reasonable efforts to execute the WHO C-TAP Commercial Development Plan submitted with its request for a license license, as may be amended pursuant to Paragraph 9.2, and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved 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, 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 thisthis 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;
(f) cannot reasonably satisfy unmet health and safety needs; or
(gf) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
Samples: Patent License Agreement (Dynamics Special Purpose Corp.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 . In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 . The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) : is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve 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) this Agreement; 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) or 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(h13.5(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(h13.5(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
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC NIAID may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC NIAID in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving IC sixty XXXXX xxxxx (60) days written notice to that effect.
13.5 IC NIAID shall specifically have the right to terminate or modify, at its option, this Agreement, if IC NIAID determines that the Licensee:
(a) is not executing the WHO C-TAP Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICXXXXX’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement;
(d) has committed a material breach of a covenant or agreement contained in this
(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; 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, IC 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 Agreement under Paragraph 13.5, IC NIAID shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICXXXXX’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate ICXXXXX’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to ICXXXXX’s satisfaction, IC NIAID may terminate this Agreement.
13.7 IC NIAID 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 ICXXXXX’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 NIAID official. The decision of the designated 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 IC NIAID shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC NIAID or provide IC NIAID with written certification of the destruction thereof. The Licensee may not be granted additional IC NIAID licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, 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 the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis 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, 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(h13.5(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(h13.5(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 reserves shall have 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 IC’s unilateral decision to modify or terminate this Agreement, require the Licensee mayto grant sublicenses to responsible applicants, consistent with the provisions on reasonable terms, in any Licensed Fields of 37 C.F.R. §404.11, appeal the decision by written submission to the designated IC official. The decision of the designated 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 Use 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide IC with written certification Rights, unless the Licensee can reasonably demonstrate that the granting of the destruction thereof. The Licensee may sublicense would not be granted additional IC licenses if materially increase the final reporting requirement is not fulfilled.availability to the public of the subject matter of the
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 . In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 '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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 . The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) : is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve 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, 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) this Agreement; 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) or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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(h13.5(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(h13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 's intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s satisfaction, IC the NIH may terminate this Agreement.
13.7 IC When the public health and safety so require, and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, the NIH shall have the right to require the Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless the Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. The NIH shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee.
13.8 The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the 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.
13.8 13.9 Within thirty (30) days of receipt of written notice of IC’s 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 IC the NIH official. The decision of the designated the 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 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 IC 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 IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC the NIH licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Start Up Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC NIAID may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC NIAID in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving IC NIAID sixty (60) days written notice to that effect.
13.5 IC NIAID shall specifically have the right to terminate or modify, at its option, this Agreement, if IC NIAID determines that the Licensee:
(a) is not executing the WHO C-TAP Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICNIAID’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement;
(d) has committed a material breach of a covenant or agreement contained in this
(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; 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, IC 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 Agreement under Paragraph 13.5, IC NIAID shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICNIAID’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate ICNIAID’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to ICNIAID’s satisfaction, IC NIAID may terminate this Agreement.
13.7 IC NIAID 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 ICNIAID’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 NIAID official. The decision of the designated 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 IC NIAID shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC NIAID or provide IC NIAID with written certification of the destruction thereof. The Licensee may not be granted additional IC NIAID licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend extend, on a Licensed Product-by-Licensed Product (or Licensed Process-by-Licensed Process) and country-by-country basis, to either the expiration of the last to expire of the Licensed Patent Rights that claims such Licensed Product (or twenty (20Licensed Process) years, whichever is longer, in such country unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC reasonably determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license license, as may be amended pursuant to Paragraph 9.2, and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis 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, 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(h13.5(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(h) or 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.
13.7 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 the 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.
13.8 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 officialofficial 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.
13.9 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 expenseexpenses, 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 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
Samples: Patent License Agreement (Dynamics Special Purpose Corp.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 '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 in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s 's satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement;
(d) has committed a material breach of a covenant or agreement contained in this
(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; 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
Samples: Patent License Agreement (Cartesian Therapeutics, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
13.3 In the event that the Licensee becomes insolventLicensee, files a petition in bankruptcy, or has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify IC the NIH in writing. Furthermore, to the extent allowed under applicable law, the NIH shall have the right to terminate this Agreement immediately upon the Licensee's receipt of written notice; provided, however, that with respect to any petition filed against the Licensee, the NIH shall not have the right to terminate this Agreement if the Licensee is able to resolve or obtain the dismissal of such petition within [*…***…] following the date of such notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any Licensed Field of Use in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this AgreementAgreement by written notice to the Licensee, if IC the NIH determines in good faith that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, 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 thisthis Agreement that has not been remedied within the ninety (90) days period set forth in Paragraph 13.2 above;
(e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f) cannot reasonably satisfy unmet health and safety needs; or
(gf) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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.. * ***Confidential Treatment Requested A-276-2014 NIH Patent License Agreement - Exclusive
13.6 In making the determination referenced in Paragraph 13.5, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICto remedy the items referenced in Paragraphs 13.5(a)-13.5(f). If the Licensee fails to alleviate the NIH’s concerns as to the items referenced in 13.5(a)-13.5(h). If Paragraphs 13.5(a)-13.5(f) within ninety (90) days following written notice from the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) NIH or otherwise fails to initiate corrective action to ICthe NIH’s satisfaction, IC the NIH may terminate this AgreementAgreement upon written notice to the Licensee.
13.7 IC When the public health and safety so require and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, the NIH shall have the right to require the Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any of the Licensed Field of Use under the Licensed Patent Rights, unless the Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. The NIH shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with the Licensee.
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 the 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 LicenseeLicensee within ninety (90) days following written notice from the NIH.
13.8 13.9 Within thirty (30) days of after receipt of written notice of IC’s 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 IC 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 13.10 Within ninety (90) days of [*…***…] after 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 IC 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 of this Agreement, the Licensee shall have the right to offer for sale and sell any existing inventory of Licensed Products for […***…] following the effective termination date of this Agreement, subject to the royalty obligations as set forth in Appendix C. After this […***…] period, the Licensee shall return all remaining Licensed Products or other materials included within the Licensed Patent Rights to IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC NIH licenses if the final reporting requirement is not fulfilled.. * ***Confidential Treatment Requested A-276-2014 NIH Patent License Agreement - Exclusive
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 '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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve 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, 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, 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(h13.5(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(h13.5(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 the 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.
13.8 13.9 Within thirty (30) days of receipt of written notice of the IC’s '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 official 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.
13.9 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 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. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.14 are not fulfilled, and shall extend on a country-by-country basis to either 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 or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee (or its Affiliate(s)) is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) calendar days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 partyThird 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 completely or in any country or territory of the Licensed Territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the unilateral right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:Licensee (or its Affiliate(s)):
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.29.1;
(c) has willfully made a false statement of, or willfully omitted, a material fact in the license application application, negotiation of this Agreement, or in any report required by this Agreement;
(d) ; has committed a material breach of a covenant or agreement contained in thisthis 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; or;
(h) has been found by a court of competent jurisdiction not provided timely annual progress or semi-annual royalty reports to have violated the Federal antitrust laws in connection with its performance IC under this AgreementArticle 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 9.29.3. 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(h13.5(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(h13.5(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 C.F.R. 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, upon termination 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 IC HHS licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent and Biological Materials License Agreement (GeoVax Labs, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 . In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 '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 or any licenses in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 . The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) : is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) ; has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) ; has willfully made a false statement of, or willfully omitted, 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) this Agreement; 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) or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 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(h13.5(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(h13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, IC 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 by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
13.3 In the event that the Licensee (i) becomes insolvent, (ii) files a petition in bankruptcy, or has such a petition filed against itit and, determines to file a in either case, such petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcyis not dismissed within sixty (60) days, the Licensee shall immediately notify IC the NIH in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC the NIH sixty (60) days written notice to that effect.
13.5 IC The NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if IC the NIH determines that the Licensee:: NIH 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 WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICthe NIH’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes;
(b) has not achieved 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, 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 thisthis Agreement;
(e) is not keeping the Licensed Products or the Licensed Processes within the scope of the Licensed Fields of Use reasonably available 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, 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, IC 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, IC the NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, ICthe NIH’s concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate ICthe NIH’s reasonable concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to ICthe NIH’s reasonable satisfaction, IC the NIH may terminate this Agreement.
13.7 IC 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 the 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
13.8 13.9 Within thirty (30) days of receipt of written notice of IC’s 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 IC 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 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 expenseexpenses, due to IC 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 IC the NIH or provide IC the NIH with written certification of the destruction thereof. The Licensee may not be granted additional IC NIH licenses if the final reporting requirement is not fulfilled.
Appears in 1 contract
Samples: Patent License Agreement (Lion Biotechnologies, Inc.)
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, parties and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 13.02 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Actnotice.
13.3 13.03 At least thirty (30) days prior to fling a petition in bankruptcy, Licensee must inform PHS in writing of its intention to file the petition in bankruptcy or of a third party’s intention to file an involuntary petition in bankruptcy.
13.04 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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement by giving Licensee written notice. Termination of this Agreement is effective upon Licensee’s receipt of the written notice.
13.4 The 13.05 Licensee shall have a unilateral right to terminate this Agreement and/or any licenses in any country or territory by giving IC PHS sixty (60) days days’ written notice to that effect.
13.5 IC 13.06 PHS shall specifically have the right to terminate or modify, at its option, this Agreement, if IC PHS determines that the Licensee:
(a: 1) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to ICPHS’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application practical application of the Licensed Products or Licensed Processes;
(b; 2) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c9.02; 3) has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement;
(dthe license agreement; 4) has committed a material substantial breach of a covenant or agreement contained in this
(ethe license; 5) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f; 6) cannot reasonably satisfy unmet health and safety safely needs; or
(gor 7) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.01 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 13.5this determination, IC shall 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 the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement9.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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
Samples: Patent License Agreement
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.16 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days [*] after the date of notice in writing of the default, IC PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 IC PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice.
13.4 The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving IC sixty (60) days PHS [*] written notice to that effect.
13.5 IC PHS shall specifically have the right to terminate or modify, at its option, this AgreementAgreement pursuant to Paragraph 13.2, if IC PHS determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to IC’s PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.2;
(c) has willfully made a false statement of, or willfully omitted, omitted a material fact in the license application or in any report required by this Agreement;; A-343-2009 PHS Patent License Agreement—Exclusive Model 10-2005 (updated 4-2010) Page 14 of 28 [Final] [GlobeImmune, Inc] [August 19, 2011] [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(d) has committed a material breach of a covenant or agreement contained in thisthis 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, 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, IC PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC PHS shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g). If the Licensee fails to alleviate IC’s PHS’ concerns as to the items referenced in 13.5(a)-13.5(h13.5(a)-13.5(g) or fails to initiate corrective action to IC’s PHS’ satisfaction, IC PHS may terminate this Agreement.
13.7 IC When the public health and safety so require, and after written notice to Licensee providing Licensee a sixty (60) day opportunity to respond, PHS shall have the right to require Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless 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. PHS shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with Licensee.
13.8 PHS reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the 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.
13.8 13.9 Within thirty (30) days of receipt of written notice of IC’s PHS’ unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. CFR §404.11404.I I, appeal the decision by written submission to the designated IC PHS official. The decision of the designated PHS 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 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 IC PHS 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 PHS 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 IC PHS or provide IC PHS with written certification of the destruction thereof. The Licensee may not be granted additional IC PHS licenses if the final reporting requirement is not fulfilled. A-343-2009 PHS Patent License Agreement—Exclusive Model 10-2005 (updated 4-2010) Page 15 of 28 [Final] [GlobeImmune, Inc] [August 19, 2011] [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Appears in 1 contract
TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 in any country or territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve 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 thisthis 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; 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(h13.5(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(h13.5(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. 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. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 14.14 are not fulfilled, and shall extend on a country-by-country basis to either 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 or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee (or its Affiliate(s)) is in default in the performance of any material obligations under this Agreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) calendar days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
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 partyThird 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 completely or in any country or territory of the Licensed Territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the unilateral right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:Licensee (or its Affiliate(s)):
(a) is not executing the WHO C-TAP Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.29.1;
(c) has willfully made a false statement of, or willfully omitted, a material fact in the license application application, negotiation of this Agreement, 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; 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, 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, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety ; (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(hd). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.
13.7 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 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. The decision of the designated 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 IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide 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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