Common use of GENTA Additional Representations, Warranties and Covenants Clause in Contracts

GENTA Additional Representations, Warranties and Covenants. GENTA hereby represents, warrants, covenants and agrees, except as set forth in detail in Schedule 17.2 (which schedule shall clearly indicate the subsection of this Section 17.2 to which an exception is being made), as follows: 17.2.1. Exhibit 1.25 constitutes a correct and complete list of all of the GENTA G3139 PATENT RIGHTS issued or pending in the TERRITORY as of the Effective Date. As of the Effective Date, GENTA has no reason to believe that any of the GENTA PATENT RIGHTS are likely to be held invalid. As of the Effective Date, to the best of GENTA's knowledge, the GENTA PATENT RIGHTS are in full force and not subject to any pending or threatened re-examination, opposition, interference or litigation proceedings. 17.2.2. To the best of GENTA's knowledge as of the Effective Date: (i) the manufacture, use or sale of COMPOUND or PRODUCT as contemplated hereunder will not infringe any valid and enforceable PATENT RIGHTS of any THIRD PARTY, and (ii) the GENTA PATENT RIGHTS with respect to PRODUCT and COMPOUND are not currently being infringed by any THIRD PARTY. 17.2.3. GENTA agrees to comply with and observe in all material respects its obligations under the GENTA THIRD PARTY AGREEMENTS, including, without limitation, its obligation to pay any royalties, sublicensing fees and other amounts due thereunder. GENTA agrees to promptly provide AVENTIS with copies of all correspondence relating to the GENTA THIRD PARTY AGREEMENTS which may impact AVENTIS' rights under this AGREEMENT. GENTA agrees not to terminate, amend, or otherwise modify or waive any of the terms or conditions of the GENTA THIRD PARTY AGREEMENTS in any manner that would adversely affecting AVENTIS' rights under this AGREEMENT without the prior written consent of AVENTIS. 17.2.4. The GENTA PATENT RIGHTS that GENTA owns or purports to own are owned, as of the Effective Date, free from any material liens or restrictions, and GENTA will not suffer or permit any material liens or restrictions to be imposed on such GENTA PATENT RIGHTS without the prior written consent of AVENTIS, unless the lien holder agrees to take such GENTA PATENT RIGHTS subject to AVENTIS' rights therein. 17.2.5. GENTA has all rights necessary under the GENTA THIRD PARTY AGREEMENTS to grant the rights and licenses granted to AVENTIS hereunder, and GENTA has not previously granted to any THIRD PARTY any rights or licenses under the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY that are inconsistent with the rights and licenses granted to AVENTIS under this AGREEMENT. 17.2.6. As of the Effective Date, each GENTA THIRD PARTY AGREEMENT is in full force and effect in accordance with its terms. As of the Effective Date, GENTA is not in default or breach of any GENTA THIRD PARTY AGREEMENT, nor has it received any notice of any defaults, breaches or violation thereunder. To the best of GENTA's knowledge as of the Effective Date, no other party to any GENTA THIRD PARTY AGREEMENT is in default or breach of such agreement. GENTA has provided AVENTIS with copies of the GENTA THIRD PARTY AGREEMENTS, as amended (to the extent that GENTA is a party to such amendment or its rights are affected thereunder), that are true, correct and complete as of the Effective Date. 17.2.7. To the best of GENTA's knowledge, there is no claim or demand of any person or entity pertaining to, or any proceeding which is pending or threatened, that challenges the rights of GENTA in respect of any GENTA PATENT RIGHTS or the GENTA TECHNOLOGY, that asserts the invalidity, misuse, unregisterability or unenforceability of any of the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY, or that claims that any default exists under any license with respect to the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY to which GENTA is a party. 17.2.8. As of the Effective Date, to the best of GENTA's knowledge, neither GENTA, nor any officer, employee or agent of GENTA, has made an untrue statement of a material fact to any REGULATORY AUTHORITY with respect to COMPOUND or PRODUCT (whether in any submission to such REGULATORY AUTHORITY or otherwise), or knowingly failed to disclose a material fact required to be disclosed to any REGULATORY AUTHORITY with respect to COMPOUND or PRODUCT. 17.2.9. To the best of GENTA's knowledge, GENTA and its employees, agents, clinical institutions and clinical investigators have complied with all FDA statutory and regulatory requirements with respect to PRODUCT and COMPOUND. 17.2.10. GENTA has disclosed to AVENTIS any facts known to GENTA as of the Effective Date that GENTA reasonably believes in good faith to be material regarding: (i) preclinical and clinical study results and protocols for COMPOUND and/or PRODUCT; (ii) any communications to and from FDA with respect to COMPOUND and/or PRODUCT, including, but not limited to, IND and NDA submissions, FDA minutes of meetings and telephone conferences; (iii) FDA requests for data and studies on COMPOUND and/or PRODUCT; and (iv) adverse drug experiences and other IND safety reports with respect to COMPOUND and/or PRODUCT.

Appears in 1 contract

Samples: u.s. Commercialization Agreement (Genta Inc De/)

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GENTA Additional Representations, Warranties and Covenants. GENTA hereby represents, warrants, covenants and agrees, except as set forth in detail in Schedule 17.2 15.2 (which schedule shall clearly indicate the subsection of this Section 17.2 15.2 to which an exception is being made), as follows: 17.2.1. 15.2.1 Exhibit 1.25 1.20, constitutes a correct and complete list of all of the GENTA G3139 PATENT RIGHTS issued or pending in the TERRITORY as of the Effective Date. As of the Effective Date, GENTA has no reason to believe that any of the GENTA PATENT RIGHTS are likely to be held invalid. As of the Effective Date, to the best of GENTA's knowledge, the GENTA PATENT RIGHTS are in full force and not subject to any pending or threatened re-examination, opposition, interference or litigation proceedings. 17.2.2. 15.2.2 To the best of GENTA's knowledge as of the Effective Date: (i) the manufacture, use or sale of COMPOUND or PRODUCT as contemplated hereunder will not infringe any valid and enforceable PATENT RIGHTS of any THIRD PARTY, and (ii) the GENTA PATENT RIGHTS with respect to PRODUCT and COMPOUND are not currently being infringed by any THIRD PARTY. 17.2.3. 15.2.3 GENTA agrees to comply with and observe in all material respects its obligations under the GENTA THIRD PARTY AGREEMENTS, including, without limitation, its obligation to pay any royalties, sublicensing fees and other amounts due thereunder. GENTA agrees to promptly provide AVENTIS with copies of all correspondence relating to the GENTA THIRD PARTY AGREEMENTS which may impact AVENTIS' rights under this AGREEMENT. GENTA agrees not to terminate, amend, or otherwise modify or waive any of the terms or conditions of the GENTA THIRD PARTY AGREEMENTS in any manner that would adversely affecting AVENTIS' rights under this AGREEMENT without the prior written consent of AVENTIS. 17.2.4. 15.2.4 The GENTA PATENT RIGHTS that GENTA owns or purports to own are owned, as of the Effective Date, free from any material liens or restrictions, and GENTA will not suffer or permit any material liens or restrictions to be imposed on such GENTA PATENT RIGHTS without the prior written consent of AVENTIS, unless the lien holder agrees to take such GENTA PATENT RIGHTS subject to AVENTIS' rights therein. 17.2.5. 15.2.5 GENTA has all rights necessary under the GENTA THIRD PARTY AGREEMENTS to grant the rights and licenses granted to AVENTIS hereunder, and GENTA has not previously granted to any THIRD PARTY any rights or licenses under the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY that are inconsistent with the rights and licenses granted to AVENTIS under this AGREEMENT. 17.2.6. 15.2.6 As of the Effective Date, each GENTA THIRD PARTY AGREEMENT is in full force and effect in accordance with its terms. As of the Effective Date, GENTA is not in default or breach of any GENTA THIRD PARTY AGREEMENT, nor has it received any notice of any defaults, breaches or violation thereunder. To the best of GENTA's knowledge as of the Effective Date, no other party to any GENTA THIRD PARTY AGREEMENT is in default or breach of such agreement. GENTA has provided AVENTIS with copies of the GENTA THIRD (*) Represents language that is redacted and subject to Confidential Treatment. PARTY AGREEMENTS, as amended (to the extent that GENTA is a party to such amendment or its rights are affected thereunder), that are true, correct and complete as of the Effective Date. 17.2.7. 15.2.7 To the best of GENTA's knowledge, there is no claim or demand of any person or entity pertaining to, or any proceeding which is pending or threatened, that challenges the rights of GENTA in respect of any GENTA PATENT RIGHTS or the GENTA TECHNOLOGY, that asserts the invalidity, misuse, unregisterability or unenforceability of any of the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY, or that claims that any default exists under any license with respect to the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY to which GENTA is a party. 17.2.8. 15.2.8 As of the Effective Date, to the best of GENTA's knowledge, neither GENTA, nor any officer, employee or agent of GENTA, has made an untrue statement of a material fact to any REGULATORY AUTHORITY with respect to COMPOUND or PRODUCT (whether in any submission to such REGULATORY AUTHORITY or otherwise), or knowingly failed to disclose a material fact required to be disclosed to any REGULATORY AUTHORITY with respect to COMPOUND or PRODUCT. 17.2.9. 15.2.9 To the best of GENTA's knowledge, GENTA and its employees, agents, clinical institutions and clinical investigators have complied with all FDA statutory and regulatory requirements with respect to PRODUCT and COMPOUND. 17.2.10. 15.2.10 GENTA has disclosed to AVENTIS any facts known to GENTA as of the Effective Date that GENTA reasonably believes in good faith to be material regarding: (i) preclinical and clinical study results and protocols for COMPOUND and/or PRODUCT; (ii) any communications to and from FDA with respect to COMPOUND and/or PRODUCT, including, but not limited to, IND and NDA submissions, FDA minutes of meetings and telephone conferences; (iii) FDA requests for data and studies on COMPOUND and/or PRODUCT; and (iv) adverse drug experiences and other IND safety reports with respect to COMPOUND and/or PRODUCT.

Appears in 1 contract

Samples: Ex u.s. Commercialization Agreement (Genta Incorporated /De/)

GENTA Additional Representations, Warranties and Covenants. GENTA hereby represents, warrants, covenants and agrees, except as set forth in detail in Schedule 17.2 15.2 (which schedule shall clearly indicate the subsection of this Section 17.2 15.2 to which an exception is being made), as follows: 17.2.115.2.1. Exhibit 1.25 1.20, constitutes a correct and complete list of all of the GENTA G3139 PATENT RIGHTS issued or pending in the TERRITORY as of the Effective Date. As of the Effective Date, GENTA has no reason to believe that any of the GENTA PATENT RIGHTS are likely to be held invalid. As of the Effective Date, to the best of GENTA's knowledge, the GENTA PATENT RIGHTS are in full force and not subject to any pending or threatened re-examination, opposition, interference or litigation proceedings. 17.2.215.2.2. To the best of GENTA's knowledge as of the Effective Date: (i) the manufacture, use or sale of COMPOUND or PRODUCT as contemplated hereunder will not infringe any valid and enforceable PATENT RIGHTS of any THIRD PARTY, and (ii) the GENTA PATENT RIGHTS with respect to PRODUCT and COMPOUND are not currently being infringed by any THIRD PARTY. 17.2.315.2.3. GENTA agrees to comply with and observe in all material respects its obligations under the GENTA THIRD PARTY AGREEMENTS, including, without limitation, its obligation to pay any royalties, sublicensing fees and other amounts due thereunder. GENTA agrees to promptly provide AVENTIS with copies of all correspondence relating to the GENTA THIRD PARTY AGREEMENTS which may impact AVENTIS' rights under this AGREEMENT. GENTA agrees not to terminate, amend, or otherwise modify or waive any of the terms or conditions of the GENTA THIRD PARTY AGREEMENTS in any manner that would adversely affecting AVENTIS' rights under this AGREEMENT without the prior written consent of AVENTIS. 17.2.415.2.4. The GENTA PATENT RIGHTS that GENTA owns or purports to own are owned, as of the Effective Date, free from any material liens or restrictions, and GENTA will not suffer or permit any material liens or restrictions to be imposed on such GENTA PATENT RIGHTS without the prior written consent of AVENTIS, unless the lien holder agrees to take such GENTA PATENT RIGHTS subject to AVENTIS' rights therein. 17.2.515.2.5. GENTA has all rights necessary under the GENTA THIRD PARTY AGREEMENTS to grant the rights and licenses granted to AVENTIS hereunder, and GENTA has not previously granted to any THIRD PARTY any rights or licenses under the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY that are inconsistent with the rights and licenses granted to AVENTIS under this AGREEMENT. 17.2.615.2.6. As of the Effective Date, each GENTA THIRD PARTY AGREEMENT is in full force and effect in accordance with its terms. As of the Effective Date, GENTA is not in default or breach of any GENTA THIRD PARTY AGREEMENT, nor has it received any notice of any defaults, breaches or violation thereunder. To the best of GENTA's knowledge as of the Effective Date, no other party to any GENTA THIRD PARTY AGREEMENT is in default or breach of such agreement. GENTA has provided AVENTIS with copies of the GENTA THIRD PARTY AGREEMENTS, as amended (to the extent that GENTA is a party to such amendment or its rights are affected thereunder), that are true, correct and complete as of the Effective Date. 17.2.715.2.7. To the best of GENTA's knowledge, there is no claim or demand of any person or entity pertaining to, or any proceeding which is pending or threatened, that challenges the rights of GENTA in respect of any GENTA PATENT RIGHTS or the GENTA TECHNOLOGY, that asserts the invalidity, misuse, unregisterability or unenforceability of any of the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY, or that claims that any default exists under any license with respect to the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY to which GENTA is a party. 17.2.815.2.8. As of the Effective Date, to the best of GENTA's knowledge, neither GENTA, nor any officer, employee or agent of GENTA, has made an untrue statement of a material fact to any REGULATORY AUTHORITY with respect to COMPOUND or PRODUCT (whether in any submission to such REGULATORY AUTHORITY or otherwise), or knowingly failed to disclose a material fact required to be disclosed to any REGULATORY AUTHORITY with respect to COMPOUND or PRODUCT. 17.2.915.2.9. To the best of GENTA's knowledge, GENTA and its employees, agents, clinical institutions and clinical investigators have complied with all FDA statutory and regulatory requirements with respect to PRODUCT and COMPOUND. 17.2.1015.2.10. GENTA has disclosed to AVENTIS any facts known to GENTA as of the Effective Date that GENTA reasonably believes in good faith to be material regarding: (i) preclinical and clinical study results and protocols for COMPOUND and/or PRODUCT; (ii) any communications to and from FDA with respect to COMPOUND and/or PRODUCT, including, but not limited to, IND and NDA submissions, FDA minutes of meetings and telephone conferences; (iii) FDA requests for data and studies on COMPOUND and/or PRODUCT; and (iv) adverse drug experiences and other IND safety reports with respect to COMPOUND and/or PRODUCT.

Appears in 1 contract

Samples: Ex u.s. Commercialization Agreement (Genta Inc De/)

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GENTA Additional Representations, Warranties and Covenants. GENTA hereby represents, warrants, covenants and agrees, except as set forth in detail in Schedule 17.2 (which schedule shall clearly indicate the subsection of this Section 17.2 to which an exception is being made), as follows: 17.2.1. 17.2.1 Exhibit 1.25 constitutes a correct and complete list of all of the GENTA G3139 PATENT RIGHTS issued or pending in the TERRITORY as of the Effective Date. As of the Effective Date, GENTA has no reason to believe that any of the GENTA PATENT RIGHTS are likely to be held invalid. As of the Effective Date, to the best of GENTA's knowledge, the GENTA PATENT RIGHTS are in full force and not subject to any pending or threatened re-examination, opposition, interference or litigation proceedings. 17.2.2. 17.2.2 To the best of GENTA's knowledge as of the Effective Date: (i) the manufacture, use or sale of COMPOUND or PRODUCT as contemplated hereunder will not infringe any valid and enforceable PATENT RIGHTS of any THIRD PARTY, and (ii) the GENTA PATENT RIGHTS with respect to PRODUCT and COMPOUND are not currently being infringed by any THIRD PARTY. 17.2.3. 17.2.3 GENTA agrees to comply with and observe in all material respects its obligations under the GENTA THIRD PARTY AGREEMENTS, including, without limitation, its obligation to pay any royalties, sublicensing fees and other amounts due thereunder. GENTA agrees to promptly provide AVENTIS with copies of all correspondence relating to the GENTA THIRD PARTY AGREEMENTS which may impact AVENTIS' rights under this AGREEMENT. GENTA agrees not to terminate, amend, or otherwise modify or waive any of the terms or conditions of the GENTA THIRD PARTY AGREEMENTS in any manner that would adversely affecting AVENTIS' rights under this AGREEMENT without the prior written consent of AVENTIS. 17.2.4. 17.2.4 The GENTA PATENT RIGHTS that GENTA owns or purports to own are owned, as of the Effective Date, free from any material liens or restrictions, and GENTA will (*) Represents language that is redacted and subject to Confidential Treatment. not suffer or permit any material liens or restrictions to be imposed on such GENTA PATENT RIGHTS without the prior written consent of AVENTIS, unless the lien holder agrees to take such GENTA PATENT RIGHTS subject to AVENTIS' rights therein. 17.2.5. 17.2.5 GENTA has all rights necessary under the GENTA THIRD PARTY AGREEMENTS to grant the rights and licenses granted to AVENTIS hereunder, and GENTA has not previously granted to any THIRD PARTY any rights or licenses under the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY that are inconsistent with the rights and licenses granted to AVENTIS under this AGREEMENT. 17.2.6. 17.2.6 As of the Effective Date, each GENTA THIRD PARTY AGREEMENT is in full force and effect in accordance with its terms. As of the Effective Date, GENTA is not in default or breach of any GENTA THIRD PARTY AGREEMENT, nor has it received any notice of any defaults, breaches or violation thereunder. To the best of GENTA's knowledge as of the Effective Date, no other party to any GENTA THIRD PARTY AGREEMENT is in default or breach of such agreement. GENTA has provided AVENTIS with copies of the GENTA THIRD PARTY AGREEMENTS, as amended (to the extent that GENTA is a party to such amendment or its rights are affected thereunder), that are true, correct and complete as of the Effective Date. 17.2.7. 17.2.7 To the best of GENTA's knowledge, there is no claim or demand of any person or entity pertaining to, or any proceeding which is pending or threatened, that challenges the rights of GENTA in respect of any GENTA PATENT RIGHTS or the GENTA TECHNOLOGY, that asserts the invalidity, misuse, unregisterability or unenforceability of any of the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY, or that claims that any default exists under any license with respect to the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY to which GENTA is a party. 17.2.8. 17.2.8 As of the Effective Date, to the best of GENTA's knowledge, neither GENTA, nor any officer, employee or agent of GENTA, has made an untrue statement of a material fact to any REGULATORY AUTHORITY with respect to COMPOUND or PRODUCT (whether in any submission to such REGULATORY AUTHORITY or otherwise), or knowingly failed to disclose a material fact required to be disclosed to any REGULATORY AUTHORITY with respect to COMPOUND or PRODUCT. 17.2.9. 17.2.9 To the best of GENTA's knowledge, GENTA and its employees, agents, clinical institutions and clinical investigators have complied with all FDA statutory and regulatory requirements with respect to PRODUCT and COMPOUND. 17.2.10. 17.2.10 GENTA has disclosed to AVENTIS any facts known to GENTA as of the Effective Date that GENTA reasonably believes in good faith to be material regarding: (i) preclinical and clinical study results and protocols for COMPOUND and/or PRODUCT; (ii) any communications to and from FDA with respect to COMPOUND and/or PRODUCT, including, but not limited to, IND and NDA submissions, FDA minutes of meetings and telephone conferences; (iii) FDA requests for data and studies on COMPOUND and/or PRODUCT; and (iv) adverse drug experiences and other IND safety reports with respect to COMPOUND and/or PRODUCT.

Appears in 1 contract

Samples: u.s. Commercialization Agreement (Genta Incorporated /De/)

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