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

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.16 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 13.2 In the event that 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, 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 Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Licensee shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice. 13.4 Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect. 13.5 PHS shall specifically have the right to terminate or modify, at its option, this Agreement pursuant to Paragraph 13.2, if PHS determines that the Licensee: (a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, 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; 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 406 of the Securities Act of 1933, as amended. (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; (f) cannot reasonably satisfy unmet health and safety needs; or (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 13.6 In making the determination referenced in Paragraph 13.5, PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS’ concerns as to the items referenced in 13.5(a)-13.5(g). If Licensee fails to alleviate PHS’ concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to PHS’ satisfaction, PHS may terminate this Agreement. 13.7 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 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 Licensee. 13.9 Within thirty (30) days of receipt of written notice of PHS’ unilateral decision to modify or terminate this Agreement, Licensee may, consistent with the provisions of 37 CFR §404.I I, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 13.10 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by 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 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, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof. Licensee may not be granted additional 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 406 of the Securities Act of 1933, as amended.

Appears in 2 contracts

Samples: Patent License Agreement (Globeimmune Inc), Patent License Agreement (Globeimmune Inc)

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TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.16 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. [***]. 13.2 In the event that 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, 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 Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Licensee shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice. 13.4 Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving PHS sixty (60) days [***] written notice to that effect. 13.5 PHS shall specifically have the right to terminate or modifyterminate, at its option, this Agreement pursuant to Paragraph 13.2or modify the Agreement, if PHS determines that the Licensee: (a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, 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; 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 406 of the Securities Act of 1933, as amended.; (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; (f) cannot reasonably satisfy unmet health and safety needs; or (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 13.6 In making the determination referenced in Paragraph 13.5, PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.513.5 or 13.8, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day [***] opportunity to respond to, PHS’ concerns as to the items referenced in 13.5(a)-13.5(g)) or 13.8 and any modifications to the scope of this Agreement intended to take effect at the end of such [***] period. If Licensee fails to alleviate PHS’ concerns as to the items referenced in 13.5(a)-13.5(g) or 13.8 or fails to initiate corrective action to PHS’ satisfaction, PHS may terminate this AgreementAgreement or, unless Licensee has terminated this Agreement itself during such [***] period, PHS may modify the scope of this Agreement as set forth in the applicable notice provided under this paragraph, provided that, in the event of an occurrence of the type described in 13.5(f), PHS shall allow Licensee the opportunity described in Paragraph 13.7 in lieu of PHS exercising any termination rights under this Article 13. 13.7 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 the Licensed Fields Field of Use in which such public health or safety issue has arisen, 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 the scope of this Agreement if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by Licensee. 13.9 Within thirty (30) days [***] of receipt of written notice of PHS’ unilateral decision to modify or terminate this AgreementAgreement to the extent permitted under this Article 13, Licensee may, consistent with the provisions of 37 CFR §404.I I404.11, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 13.10 Within ninety (90) days [***] of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by Licensee. Any royalty payments, including those incurred but not yet paid (such as the full any minimum annual royaltyroyalty due but not yet paid), and those related to patent expense, due to 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, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof. Licensee may not be granted additional 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 406 of the Securities Act of 1933, as amended.

Appears in 2 contracts

Samples: Patent License Agreement (Erytech Pharma S.A.), Patent License Agreement (Erytech Pharma)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.16 are not fulfilled, parties and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 13.2 13.02 In the event that 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, 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-(Nonexclusive)- L-165-99/0 Trinity Biotech Plc Final 11/23/99 Model 980611 Page 7 of 18 13.3 13.03 In the event that Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Licensee shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice. 13.4 13.04 Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect. 13.5 13.05 PHS shall specifically have the right to terminate or modify, at its option, this Agreement pursuant to Paragraph 13.2Agreement, if PHS determines that the Licensee: (a: 1) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; (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 omitted, a material fact in the license application or in any report required by this the license 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 406 of the Securities Act of 1933, as amended. (d) has committed a material breach of a covenant or agreement contained in this Agreement; (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. 13.6 . In making the determination referenced in Paragraph 13.5this determination, PHS shall will take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS’ concerns as to the items referenced in 13.5(a)-13.5(g). If Licensee fails to alleviate PHS’ concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to PHS’ satisfaction, PHS may terminate this Agreement9. 13.7 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 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 Licensee. 13.9 Within thirty (30) days of receipt of written notice of PHS’ unilateral decision to modify or terminate this Agreement, Licensee may, consistent with the provisions of 37 CFR §404.I I, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 13.10 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by 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 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, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof. Licensee may not be granted additional 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 406 of the Securities Act of 1933, as amended.

Appears in 1 contract

Samples: Patent License Agreement (Trinity Biotech PLC)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless AGREEMENT shall begin on the provisions of Paragraph 14.16 are not fulfilled, EFFECTIVE DATE and shall extend to the expiration of the last to expire of the Licensed Patent Rights LICENSED PATENT RIGHTS unless sooner terminated as provided in this Article 13. 13.2 13.02 In the event that 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 13.513.05, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the such default, 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 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, Licensee LICENSEE shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement AGREEMENT immediately upon Licensee’s LICENSEE's receipt of written notice. 13.4 Licensee 13.04 LICENSEE shall have a unilateral right to terminate this Agreement or AGREEMENT and/or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect. 13.5 13.05 PHS shall specifically have the right to terminate or modify, at its option, this Agreement pursuant to Paragraph 13.2AGREEMENT, if PHS determines that the Licensee: (aLICENSEE: 1) is not executing the Commercial Development Plan COMMERCIAL DEVELOPMENT PLAN submitted with its request for a license and the Licensee LICENSEE cannot otherwise demonstrate or reasonably justify to 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; 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 406 of the Securities Act of 1933, as amended9. (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; (f) cannot reasonably satisfy unmet health and safety needs; or (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 13.6 In making the determination referenced in Paragraph 13.5, PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS’ concerns as to the items referenced in 13.5(a)-13.5(g). If Licensee fails to alleviate PHS’ concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to PHS’ satisfaction, PHS may terminate this Agreement. 13.7 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 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 Licensee. 13.9 Within thirty (30) days of receipt of written notice of PHS’ unilateral decision to modify or terminate this Agreement, Licensee may, consistent with the provisions of 37 CFR §404.I I, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 13.10 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by 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 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, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof. Licensee may not be granted additional 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 406 of the Securities Act of 1933, as amended.

Appears in 1 contract

Samples: PHS Patent License Agreement (Zonagen Inc)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.16 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. 13.2 In the event that 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, 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 Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Licensee shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice. 13.4 Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect. 13.5 PHS shall specifically have the right to terminate or modify, at its option, this Agreement pursuant to Paragraph 13.2Agreement, if PHS determines that the Licensee: (a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, 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-343A-196-2009 2011 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 406 of the Securities Act of 1933, as amended.Nonexclusive_Sublicense (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; (f) cannot reasonably satisfy unmet health and safety needs; or (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 5.2, unless waived. 13.6 In making the determination referenced in Paragraph 13.5, PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS’ concerns as to the items referenced in 13.5(a)-13.5(g). If Licensee fails to alleviate PHS’ concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to PHS’ satisfaction, PHS may terminate this Agreement. 13.7 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 this 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 Licensee. 13.9 13.8 Within thirty (30) days of receipt of written notice of PHS’ unilateral decision to modify or terminate this Agreement, Licensee may, consistent with the provisions of 37 CFR C.F.R. §404.I I404.11, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 13.10 13.9 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by 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 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, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with written certification of the destruction thereof. Licensee may not be granted additional 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 406 of the Securities Act of 1933, as amended.

Appears in 1 contract

Samples: Patent License Agreement (Genesis Biopharma, Inc)

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 14.16 14.17 are not fulfilled, and shall extend to the expiration or termination of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 13.2 In the event that 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, 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 Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Licensee shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice. 13.4 Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect. 13.5 Subject to Paragraph 13.5, PHS shall specifically have the right to terminate or modify, at its option, this Agreement pursuant to Paragraph 13.2Agreement, if PHS determines that the Licensee: (a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, 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 the license 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 406 of the Securities Act of 1933, as amended.; (d) has committed a material breach of a material covenant or material agreement contained in this Agreement; (e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; (f) cannot reasonably 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 unless waived. 13.6 In making the determination referenced in Paragraph 13.5, PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS’ concerns as to the items referenced in 13.5(a)-13.5(g). If Licensee fails to alleviate PHS’ concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to PHS’ satisfaction, PHS PHS, subject to Paragraph 13.8, may modify or terminate this Agreement. 13.7 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 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 Licensee. 13.9 Within thirty (30) days of receipt of written notice of PHS’ unilateral decision to modify or terminate this Agreement, Licensee may, consistent with the provisions of 37 CFR §404.I I404.11, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 13.10 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by 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 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, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof. Licensee may not be granted additional 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 406 24b-2 of the Securities Exchange Act of 19331934, as amended.

Appears in 1 contract

Samples: Patent License Agreement (Globeimmune Inc)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.16 are not fulfilled, and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 13.2 In the event that 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, 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 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, Licensee shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s 's receipt of written notice. 13.4 Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect. 13.5 PHS shall specifically have the right to terminate or modify, at its option, this Agreement pursuant Agreement, subject to Paragraph paragraph 13.2, if PHS determines that the Licensee: (a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’ reasonable satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; (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 the license 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 406 of the Securities Act of 1933, as amended.; (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; (f) cannot reasonably satisfy unmet health and safety needs; or (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 13.6 In making the determination referenced in Paragraph 13.5, PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS’ concerns as to the items referenced in 13.5(a)-13.5(g). If Licensee fails to alleviate PHS’ concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to PHS’ reasonable satisfaction, PHS may terminate this Agreement. 13.7 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 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 Licensee. 13.9 Within thirty (30) days of receipt of written notice of PHS' unilateral decision to modify or terminate this Agreement, Licensee may, consistent with the provisions of 37 CFR §404.I I404.11, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 13.10 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by 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 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, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof. Licensee may not be granted additional 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 406 of the Securities Act of 1933, as amended.

Appears in 1 contract

Samples: Patent License Agreement (Lixte Biotechnology Holdings, Inc.)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.16 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. 13.2 In the event that 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, 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 Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Licensee shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice. 13.4 Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect. 13.5 PHS shall specifically have the right to terminate or modify, at its option, this Agreement pursuant to Paragraph 13.2, if PHS determines that the Licensee: (a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, 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; 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 406 24b-2 of the Securities Exchange Act of 19331934, as amended. (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; (f) cannot reasonably satisfy unmet health and safety needs; or (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 13.6 In making the determination referenced in Paragraph 13.5, PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS’ concerns as to the items referenced in 13.5(a)-13.5(g). If Licensee fails to alleviate PHS’ concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to PHS’ satisfaction, PHS may terminate this Agreement. 13.7 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 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 Licensee. 13.9 Within thirty (30) days of receipt of written notice of PHS’ unilateral decision to modify or terminate this Agreement, Licensee may, consistent with the provisions of 37 CFR §404.I I, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 13.10 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by 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 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, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof. Licensee may not be granted additional 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 406 24b-2 of the Securities Exchange Act of 19331934, as amended.

Appears in 1 contract

Samples: Patent License Agreement (Globeimmune Inc)

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TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.16 are not fulfilled, parties and shall extend on a country by country basis to the expiration of the last to expire of the Licensed Patent Rights in each respective country unless sooner terminated as provided in this Article 13. 13.2 13.02 In the event that 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, PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Actnotice. 13.3 In 13.03 in the event that Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s 's intention to file an involuntary petition in bankruptcy, Licensee shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice. 13.4 13.04 Licensee shall have a unilateral right to terminate this Agreement or and/or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect. 13.5 13.05 PHS shall specifically have the right to terminate or modify, at its option, this Agreement pursuant to Paragraph 13.2Agreement, if PHS determines that the Licensee: (aLicensee acting on its own or through its agents: 1) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS's reasonable satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; (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 omitted, a material fact in the license application or in any report required by this Agreementthe license 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 406 of the Securities Act of 1933, as amended. (d) has committed a material breach of a covenant or agreement contained in this Agreement; (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 unless waived. 13.6 In making the determination referenced in Paragraph 13.5, PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS’ concerns as to the items referenced in 13.5(a)-13.5(g). If Licensee fails to alleviate PHS’ concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to PHS’ satisfaction, PHS may terminate this Agreement. 13.7 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 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 Licensee. 13.9 Within thirty (30) days of receipt of written notice of PHS’ unilateral decision to modify or terminate this Agreement, Licensee may, consistent with the provisions of 37 CFR §404.I I, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 13.10 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by 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 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, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof. Licensee may not be granted additional 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 406 of the Securities Act of 1933, as amended.5.02

Appears in 1 contract

Samples: Patent License Agreement (Sciclone 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 14.16 are not fulfilled, parties and shall extend to the expiration of the last to expire of the Licensed Patent Rights licensed patent rights unless sooner terminated as provided in this Article 13. 13.2 13.02 In the event that 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, 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 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. 13.04 In the event that 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, Licensee LICENSEE shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately by giving LICENSEE written notice. Termination of this Agreement is effective upon Licensee’s LICENSEE's receipt of the written notice. 13.4 Licensee 13.05 LICENSEE shall have a unilateral right to terminate this Agreement or and/or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect. 13.5 13.06 PHS shall specifically have the right to terminate or modify, modify at its option, option this Agreement pursuant to Paragraph 13.2, if PHS determines that the Licensee: LICENSEE: (a1) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee LICENSEE cannot otherwise demonstrate to PHS's satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; (b) has not achieved the Benchmarks as may be modified under Paragraph 9.2; (c) has willfully made a false statement of, or willfully omitted a material fact in the license application or in any report required by this Agreement; A-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 406 of the Securities Act of 1933, as amended. (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; (f) cannot reasonably satisfy unmet health and safety needs; or (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived. 13.6 In making the determination referenced in Paragraph 13.5, PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS’ concerns as to the items referenced in 13.5(a)-13.5(g). If Licensee fails to alleviate PHS’ concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to PHS’ satisfaction, PHS may terminate this Agreement. 13.7 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 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 Licensee. 13.9 Within thirty (30) days of receipt of written notice of PHS’ unilateral decision to modify or terminate this Agreement, Licensee may, consistent with the provisions of 37 CFR §404.I I, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 13.10 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by 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 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, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof. Licensee may not be granted additional 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 406 of the Securities Act of 1933, as amended.that

Appears in 1 contract

Samples: Sublicense Agreement (Somanta Pharmaceuticals Inc.)

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.16 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. [***]. 13.2 In the event that 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, 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 Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, Licensee shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice. 13.4 Licensee shall have a unilateral right to terminate this Agreement or any licenses in any country or territory by giving PHS sixty (60) days [***] written notice to that effect. 13.5 PHS shall specifically have the right to terminate or modifyterminate, at its option, this Agreement pursuant to Paragraph 13.2or modify the Agreement, if PHS determines that the Licensee: (a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’ satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, 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; 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 406 of the Securities Act of 1933, as amended.; (d) has committed a material breach of a covenant or agreement contained in this Agreement; (e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences; (f) cannot reasonably satisfy unmet health and safety needs; or (g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived.. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 230.406 13.6 In making the determination referenced in Paragraph 13.5, PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.513.5 or 13.8, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day [***] opportunity to respond to, PHS’ concerns as to the items referenced in 13.5(a)-13.5(g)) or 13.8 and any modifications to the scope of this Agreement intended to take effect at the end of such [***] period. If Licensee fails to alleviate PHS’ concerns as to the items referenced in 13.5(a)-13.5(g) or 13.8 or fails to initiate corrective action to PHS’ satisfaction, PHS may terminate this AgreementAgreement or, unless Licensee has terminated this Agreement itself during such [***] period, PHS may modify the scope of this Agreement as set forth in the applicable notice provided under this paragraph, provided that, in the event of an occurrence of the type described in 13.5(f), PHS shall allow Licensee the opportunity described in Paragraph 13.7 in lieu of PHS exercising any termination rights under this Article 13. 13.7 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 the Licensed Fields Field of Use in which such public health or safety issue has arisen, 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 the scope of this Agreement if it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by Licensee. 13.9 Within thirty (30) days [***] of receipt of written notice of PHS’ unilateral decision to modify or terminate this AgreementAgreement to the extent permitted under this Article 13, Licensee may, consistent with the provisions of 37 CFR §404.I I404.11, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 13.10 Within ninety (90) days [***] of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by Licensee. Any royalty payments, including those incurred but not yet paid (such as the full any minimum annual royaltyroyalty due but not yet paid), and those related to patent expense, due to 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, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof. Licensee may not be granted additional 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 406 of the Securities Act of 1933, as amended.

Appears in 1 contract

Samples: Patent License Agreement

TERM, TERMINATION, AND MODIFICATION OF RIGHTS. 13.1 13.01 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.16 are not fulfilled, parties and shall extend to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13. 13.2 13.02 In the event that 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, PHS may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.notice, 13.3 13.03 In the event that Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s 's intention to file an involuntary petition in bankruptcy, Licensee shall immediately notify PHS in writing. Furthermore, PHS shall have the right to terminate this Agreement immediately upon Licensee’s receipt of written notice. 13.4 13.04 Licensee shall have a unilateral right to terminate this Agreement or and/or any licenses in any country or territory by giving PHS sixty (60) days written notice to that effect. 13.5 13.05 PHS shall specifically have the right to terminate or modify, at its option, this Agreement pursuant to Paragraph 13.2Agreement, if PHS determines that the Licensee: (a: 1) is not using reasonable best efforts in executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to PHS’ PIIS's satisfaction that the Licensee has taken, or can be expected to take within svizlein 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 from time to time by prior mutual written consent under Paragraph 9.2; (c9.02; 3) 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 Agreementthe license 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 406 of the Securities Act of 1933, as amended. (d) has committed a material breach of a covenant or agreement contained in this Agreement; (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. 13.6 . In making the determination referenced in Paragraph 13.5this determination, PHS shall will take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.29. 02. Prior to invoking termination or modification of this Agreement under Paragraph 13.5right, PHS shall give written notice to Licensee providing Licensee specific notice of, and a ninety (90) day opportunity to respond to, PHS's concerns as to the previous items referenced in 13.5(a)-13.5(g1) to 7). If Licensee fails to alleviate PHS's concerns as to the previous items referenced in 13.5(a)-13.5(g1) to 7) or fails to initiate corrective action to PHS's satisfaction, PHS may terminate this Agreement. 13.7 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 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 Licensee. 13.9 Within thirty (30) days of receipt of written notice of PHS’ unilateral decision to modify or terminate this Agreement, Licensee may, consistent with the provisions of 37 CFR §404.I I, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available. 13.10 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by 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 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, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof. Licensee may not be granted additional 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 406 of the Securities Act of 1933, as amended.

Appears in 1 contract

Samples: Patent License Agreement (Angiotech Pharmaceuticals Inc)

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