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

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 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. In the event that the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify the IC in writing. The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving the IC sixty (60) days written notice to that effect. The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee: is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; has not achieved the Benchmarks as may be modified under Paragraph 9.2; has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived. has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement. In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement. 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. 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. 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: Public Health Service, Public Health Service

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TERM, TERMINATION, AND MODIFICATION OF RIGHTS. This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 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. In the event that the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify the IC in writing. The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving the IC sixty (60) days written notice to that effect. The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee: is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; has not achieved the Benchmarks as may be modified under Paragraph 9.2; has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived. has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement. In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement. 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. 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. 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

Samples: Public Health Service, Public Health Service

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 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 expire at the expiration time specified in Appendix B, unless previously terminated under the terms of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 137. 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. In the event that the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify the IC in writing. The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving the IC sixty (60) days written notice to that effect. The IC shall specifically have the right to terminate or modify, at its option, this Agreement, Agreement by written notice if the IC determines that the Licensee: has not demonstrated that it is not executing the Commercial 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 the 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; has not achieved the Benchmarks as may be modified under Paragraph 9.2; 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; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived. has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement. In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement. 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. 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 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 availableaccessible. 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: Public Health Service, Public Health Service

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 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 the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 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, the IC VA may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act, 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 the IC VA in writing. 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 the IC sixty (60) 180 days written notice to that effect. The IC VA shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC VA determines that the LicenseeLICENSEE: is not executing the Commercial Development Plan submitted with its request for a license and the Licensee LICENSEE cannot otherwise demonstrate to the 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; has not achieved the Benchmarks as may be modified under Paragraph 9.2; 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; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.2 unless waived. 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. In making the determination referenced in Paragraph 13.5public health and safety so require, 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 after written notice to the Licensee LICENSEE providing the Licensee specific notice of, and LICENSEE a ninety sixty (9060) day opportunity to respond torespond, VA shall have the IC’s concerns as 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(g)good faith with LICENSEE. If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement. The 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 LicenseeLICENSEE. Within thirty (30) days of receipt of written notice of the 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 the IC VA official. The decision of the designated IC 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. 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 the 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 the IC VA or provide the 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

Samples: Patent License Agreement – Exclusive, Patent License Agreement – Exclusive

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 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 the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 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 NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. 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 NIH in writing. The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving the IC NIH sixty (60) days written notice to that effect. The IC NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC NIH determines that the Licensee: is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the ICNIH’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; has not achieved the Benchmarks as may be modified under Paragraph 9.2; 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; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping the Licensed Products or the Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.2 unless waived. has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement. In making the determination referenced in Paragraph 13.5, the IC NIH shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the ICNIH’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the ICNIH’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the ICNIH’s satisfaction, the IC NIH may terminate this Agreement. When the public health and safety so require, and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, the NIH shall have the right to require the Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless the Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. The IC 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. Within thirty (30) days of receipt of written notice of the IC’s 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 the IC NIH official. The decision of the designated IC NIH official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be availableaccessible. 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 NIH shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with the NIH pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to the IC NIH or provide the IC 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. This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 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. In the event that the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify the IC in writing. The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving the IC sixty (60) days written notice to that effect. The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee: is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; has not achieved the Benchmarks as may be modified under Paragraph 9.2; has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived. has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement. In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement. 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. 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. 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: Public Health Service

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 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 the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 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. 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. 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. The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee: is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes; has not achieved the Benchmarks as may be modified under Paragraph 9.2; 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; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping the Licensed Products or the Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.2 unless waived. has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement. In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement. 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. 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. 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: Public Health Service

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 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 expire at the expiration time specified in Appendix B, unless previously terminated under the terms of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 137. 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. In the event that the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify the IC in writing. The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving the IC sixty (60) days written notice to that effect. The IC shall specifically have the right to terminate or modify, at its option, this Agreement, Agreement by written notice if the IC determines that the Licensee: has not demonstrated that it is not executing the Commercial 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 the 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; has not achieved the Benchmarks as may be modified under Paragraph 9.2; 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; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived. has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement. In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement. 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. 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 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 availableaccessible. 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. 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 1 contract

Samples: Public Health Service

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 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 the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 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. 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. 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. The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee: is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; has not achieved the Benchmarks as may be modified under Paragraph 9.2; has willfully made a false statement of, or willfully omitted, omitted a material fact in the license application or in any report required by this Agreement; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.2 unless waived. has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement. In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement. 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. 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. 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: Public Health Service

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 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 the expiration of the last to expire of the Licensed Patent Rights LICENSED PATENT RIGHTS unless sooner terminated as provided in this Article 13. 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, the IC VA may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. 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 the IC VA in writing. 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 the IC sixty (60) 180 days written notice to that effect. The IC VA shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC VA determines that the LicenseeLICENSEE: is not executing the Commercial Development Plan COMMERCIAL DEVELOPMENT PLAN submitted with its request for a license and the Licensee LICENSEE cannot otherwise demonstrate to the 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 ProcessesLICENSED PROCESSES; has not achieved the Benchmarks BENCHMARKS as may be modified under Paragraph 9.2; 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; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping Licensed Products LICENSED PRODUCTS or Licensed Processes LICENSED PROCESSES reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.2 unless waived. has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement. In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement. The 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 LicenseeLICENSEE. Within thirty (30) days of receipt of written notice of the 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 the IC VA official. The decision of the designated IC 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. 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 the 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 the IC VA or provide the IC VA with written certification of the destruction thereof. GENERAL PROVISIONS 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. SIGNATURES BEGIN ON NEXT PAGE VA PATENT LICENSE AGREEMENT – EXCLUSIVE 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). APPENDIX A – PATENT(S) OR PATENT APPLICATION(S) Patent(s) or Patent Application(s): APPENDIX B – LICENSED FIELDS OF USE AND TERRITORY LICENSED FIELDS OF USE: LICENSED TERRITORY:

Appears in 1 contract

Samples: Patent License Agreement – Non Exclusive

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TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 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 the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 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. 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. 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. The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee: is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical Application of the Licensed Products or the Licensed Processes; has not achieved the Benchmarks as may be modified under Paragraph 9.2; 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; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping the Licensed Products or the Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.2 unless waived. ; 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. In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement. 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. 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. 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: Public Health Service

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 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. In the event that the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify the IC in writing. The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving the IC sixty (60) days written notice to that effect. The IC shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee: is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; has not achieved the Benchmarks as may be modified under Paragraph 9.2; has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived. has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement. In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement. 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. 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. 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: Public Health Service

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 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 expire at the expiration time specified in Appendix B, unless previously terminated under the terms of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 137. 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 NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. In the event that the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify the IC in writing. The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving the IC sixty (60) days written notice to that effect. The IC NIH shall specifically have the right to terminate or modify, at its option, this Agreement, Agreement by written notice if the IC determines that the Licensee: has not demonstrated that it is not executing the Commercial 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 the 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; has not achieved the Benchmarks as may be modified under Paragraph 9.2; 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; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived. has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement. In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC’s satisfaction, the IC may terminate this Agreement. The IC 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 Federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee. The Licensee shall have a unilateral right to terminate this Agreement by giving the NIH sixty (60) days written notice to that effect. Within thirty (30) days of receipt of written notice of the ICNIH’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 Director of the IC officialNIH or designee. The decision of the designated IC official NIH Director or designee shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 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 NIH at the Mailing Address for Agreement notices 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 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 the IC NIH or provide the IC NIH with written certification of the destruction thereof. If the term of the Agreement is extended at the Licensee’s request, then the NIH 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 NIH may request a status update report after the fifth (5th) year of the Agreement; and The Licensee may not be granted additional IC NIH 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 1 contract

Samples: Non‑exclusive Patent License Agreement

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 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 the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 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 NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. 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 NIH in writing. The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving the IC NIH sixty (60) days written notice to that effect. The IC NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC NIH determines that the Licensee: is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the ICNIH’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; has not achieved the Benchmarks as may be modified under Paragraph 9.2; 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; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, 5.2 unless waived. has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement. In making the determination referenced in Paragraph 13.5, the IC NIH shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the ICNIH’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the ICNIH’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the ICNIH’s satisfaction, the IC NIH may terminate this Agreement. When the public health and safety so require, and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, the NIH shall have the right to require the Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless the Licensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. The IC 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. Within thirty (30) days of receipt of written notice of the IC’s 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 the IC NIH official. The decision of the designated IC 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. 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 NIH shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with the NIH pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to the IC NIH or provide the IC 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: Patent License Agreement

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 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 NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act. 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 NIH in writing. The Licensee shall have a unilateral right to terminate this Agreement in any country or territory by giving the IC NIH sixty (60) days written notice to that effect. The IC NIH shall specifically have the right to terminate or modify, at its option, this Agreement, if the IC NIH determines that the Licensee: is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the ICNIH’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; has not achieved the Benchmarks as may be modified under Paragraph 9.2; has willfully made a false statement of, or willfully omitted, a material fact in the license application or in any report required by this Agreement; has committed a material breach of a covenant or agreement contained in this Agreement; is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; cannot reasonably satisfy unmet health and safety needs; or cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived. has been found by a court of competent jurisdiction to have violated the Federal antitrust laws in connection with its performance under this Agreement. In making the determination referenced in Paragraph 13.5, the IC NIH shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC NIH shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the ICNIH’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the ICNIH’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the ICNIH’s satisfaction, the IC NIH may terminate this Agreement. The IC 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. Within thirty (30) days of receipt of written notice of the ICNIH’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 NIH official. The decision of the designated IC 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. 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 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 the IC NIH or provide the IC 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

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