Additional Amgen Warranties. Amgen warrants to Company that: (a) As of the Signing Date, Amgen Controls the Licensed Patents and the Licensed Know-How listed on the Licensed Know-How Schedule, and is entitled to grant the licenses specified herein. Amgen has not caused any Patent Right included in the Licensed Patents to be subject to any liens or encumbrances and Amgen has not granted to any Third Party any rights or licenses under such Patent Rights or Licensed Know-How that would conflict with the licenses granted to Company hereunder. None of the Licensed Patents are in-licensed by Amgen; (b) As of the Signing Date, Amgen has no knowledge of any claim or litigation that has been brought or threatened in writing by any Third Party alleging that (i) the Licensed Patents are invalid or unenforceable or (ii) the manufacture, sale, offer for sale or importation of the Product in the Field in the Territory infringes or misappropriates any patents or other intellectual property rights of any Third Party; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. (c) As of the Signing Date, no patent application or registration within the Licensed Patents is the subject of any pending interference, opposition, cancellation or patent protest pursuant to 37 C.F.R. § 1.291; (d) Amgen has made available to Company true and correct copies of the following: (i) all material Regulatory Filings for the Territory; (ii) all material correspondence with Governmental Authorities with respect to such Regulatory Filings; (iii) all minutes of any material meetings, telephone conferences or discussions with Governmental Authorities with respect to such Regulatory Filings; and (iv) all final clinical trial reports, in each case with respect to the Product and to the extent in existence as of the Signing Date; (e) Until ownership of any Regulatory Filing is transferred to Company as set forth herein, Amgen is the owner of each such Regulatory Filing in the Field in the Territory; (f) All the Product Lots provided to Company by Amgen pursuant to the Supply Agreement, as of the date each such Product Lot is provided to Company as set forth herein, have been manufactured, packaged, stored and labeled (as applicable) in accordance with cGMP and the specifications set forth in the Specifications Schedule; (g) As of the Signing Date, the copy of the Japan Agreement and each Pre-Existing Agreement disclosed to Company prior to the Signing Date is, but for the redactions contained therein, a true and complete copy. Amgen further represents and warrants that Company will not be bound by any provision that is redacted from such copies of the Japan Agreement and/or any Pre-Existing Agreement; (h) as of the Signing Date, [*], and (ii) [*]; and (i) As of the Signing Date, Amgen has no knowledge that the manufacture of the Product using the Amgen Cell Line provided under this Agreement would infringe any patents of any Third Party.
Appears in 3 contracts
Samples: Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.)
Additional Amgen Warranties. Amgen warrants to Company that:
(a) As of the Signing Date, Amgen Controls the Licensed Patents and the Licensed Know-How listed on the Licensed Know-How Schedule, and is entitled to grant the licenses specified herein. Amgen has not caused any Patent Right included in the Licensed Patents to be subject to any liens or encumbrances and Amgen has not granted to any Third Party any rights or licenses under such Patent Rights or Licensed Know-How that would conflict with the licenses granted to Company hereunder. None of the Licensed Patents are in-licensed by Amgen;
(b) As of the Signing Date, Amgen has no knowledge of any claim or litigation that has been brought or threatened in writing by any Third Party alleging that (i) the Licensed Patents are invalid or unenforceable or (ii) the manufacture, sale, offer for sale or importation of the Product Products in the Field in the Territory infringes or misappropriates any patents or other intellectual property rights of any Third Party; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.;
(c) As of the Signing Date, except as set forth on the Disclosure Schedule, no patent application or registration within the Licensed Patents is the subject of any pending interference, opposition, cancellation or patent protest pursuant to 37 C.F.R. § 1.291;
(d) Amgen has made available to Company true and correct copies of the following: (i) all material Regulatory Filings for the Territory; (ii) all material correspondence with Governmental Authorities with respect to such Regulatory Filings; (iii) all minutes of any material meetings, telephone conferences or discussions with Governmental Authorities with respect to such Regulatory Filings; and (iv) all final clinical trial reports, in each case with respect to the Product Products and to the extent in existence as of the Signing Date;
(e) Until ownership of any Regulatory Filing is transferred to Company as set forth herein, Amgen is the owner of each such Regulatory Filing in the Field in the Territory;
(f) All Intentionally omitted; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Product Lots provided to Company by Amgen Securities and Exchange Commission pursuant to Rule 406 of the Supply AgreementSecurities Act of 1933, as of the date each such Product Lot is provided to Company as set forth herein, have been manufactured, packaged, stored and labeled (as applicable) in accordance with cGMP and the specifications set forth in the Specifications Schedule;amended.
(g) As of the Signing Date, the copy of the Japan Agreement and each Pre-Existing Agreement disclosed to Company prior to the Signing Date is, but for the redactions contained therein, a true and complete copy. Amgen further represents and warrants that Company will not be bound by any provision that is redacted from such copies of the Japan Agreement and/or any Pre-Existing Agreement;
(h) as of the Signing Date, [*], and (ii) [*]; and
(ih) As of the Signing Date, Amgen has no knowledge that the manufacture of the Product Products using the Amgen Cell Line Lines provided under this Agreement would infringe any patents of any Third PartyParty in a manner that would reasonably be expected to have a material adverse effect on Company’s ability to Commercialize the Products on or after January 1, 2019.
Appears in 3 contracts
Samples: Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.)
Additional Amgen Warranties. Amgen AMGEN represents and warrants that, as of the Effective Date (except with respect to Company that:clause (f) below):
(a) As of the Signing Date, Amgen AMGEN Controls the Patent Rights listed on Exhibit B and such Licensed Patents and are subject to the licenses granted to AKERO pursuant to this Agreement;
(b) AMGEN has the rights necessary to grant the licenses to AKERO to Licensed Know-How listed set forth on the Licensed Know-How ScheduleExhibit A that AMGEN grants pursuant to this Agreement;
(c) To AMGEN’s knowledge, and is entitled to grant the licenses specified herein. Amgen has not caused any Patent Right included in the Licensed Patents to be constitute [***] as of the Effective Date [***];
(d) The Patent Rights listed on Exhibit B are not subject to any liens or encumbrances and Amgen AMGEN has not granted to any Third Party any rights or licenses under such Patent Rights or Licensed Know-How that would conflict with the licenses granted to Company AKERO hereunder. None of the Licensed Patents are is in-licensed by Amgen;
(b) As of the Signing Date, Amgen has no knowledge of any claim or litigation that has been brought or threatened in writing by any Third Party alleging that (i) the Licensed Patents are invalid or unenforceable or (ii) the manufacture, sale, offer for sale or importation of the Product in the Field in the Territory infringes or misappropriates any patents or other intellectual property rights of any Third Party; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(c) As of the Signing Date, no AMGEN. No patent application or registration within the Licensed Patents is the subject of any pending interference, opposition, cancellation or patent protest pursuant to 37 C.F.R. § 1.291;
(d) Amgen has made available to Company true and correct copies of the following: (i) all material Regulatory Filings for the Territory; (ii) all material correspondence with Governmental Authorities with respect to such Regulatory Filings; (iii) all minutes of any material meetings, telephone conferences or discussions with Governmental Authorities with respect to such Regulatory Filings; and (iv) all final clinical trial reports, in each case with respect to the Product and to the extent in existence as of the Signing Date§1.291 unless otherwise noted on Exhibit B;
(e) Until ownership With the exception of Patent [***], AMGEN has no knowledge of any Regulatory Filing is transferred to Company as set forth hereinclaim or litigation that has been brought or threatened in writing by any Third Party alleging that the Licensed Patents are invalid or unenforceable or that the manufacture, Amgen is sale, offer for sale, or importation of the owner of each such Regulatory Filing Product in the Licensed Field in the Territory;infringes or misappropriates or would infringe or misappropriate any right of any Third Party; and
(f) All the Product Lots provided to Company AKERO by Amgen AMGEN pursuant to the Supply AgreementSection 5.4, as of the date each such Product Lot is provided to Company AKERO, shall conform to the applicable specifications and, to the extent identified as set forth hereincGMP materials in Exhibit A, shall have been manufactured, packaged, stored and labeled (as applicable) in accordance with cGMP and the specifications set forth in the Specifications Schedule;
(g) As of the Signing Date, the copy of the Japan Agreement and each Pre-Existing Agreement disclosed to Company prior to the Signing Date is, but for the redactions contained therein, a true and complete copy. Amgen further represents and warrants that Company will not be bound by any provision that is redacted from such copies of the Japan Agreement and/or any Pre-Existing Agreement;
(h) as of the Signing Date, [*], and (ii) [*]; and
(i) As of the Signing Date, Amgen has no knowledge that the manufacture of the Product using the Amgen Cell Line provided under this Agreement would infringe any patents of any Third PartycGMP.
Appears in 3 contracts
Samples: Exclusive License Agreement (Akero Therapeutics, Inc.), Exclusive License Agreement (Akero Therapeutics, Inc.), Exclusive License Agreement (Akero Therapeutics, Inc.)
Additional Amgen Warranties. Amgen warrants to Company that:
(a) As of the Signing Date, Amgen Controls the Licensed Patents and the Licensed Know-How listed on the Licensed Know-How Schedule, and is entitled to grant the licenses specified herein. Amgen has not caused any Patent Right included in the Licensed Patents to be subject to any liens or encumbrances and Amgen has not granted to any Third Party any rights or licenses under such Patent Rights or Licensed Know-How that would conflict with the licenses granted to Company hereunder. None of the Licensed Patents are in-licensed by Amgen;
(b) As of the Signing Date, Amgen has no knowledge of any claim or litigation that has been brought or threatened in writing by any Third Party alleging that (i) the Licensed Patents are invalid or unenforceable or (ii) the manufacture, sale, offer for sale or importation of the Product Products in the Field in the Territory infringes or misappropriates any patents or other intellectual property rights of any Third Party; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.;
(c) As of the Signing Date, no patent application or registration within the Licensed Patents is the subject of any pending interference, opposition, cancellation or patent protest pursuant to 37 C.F.R. § 1.291;
(d) Amgen has made available to Company true and correct copies of the following: (i) all material Regulatory Filings for the Territory; (ii) all material correspondence with Governmental Authorities with respect to such Regulatory Filings; (iii) all minutes of any material meetings, telephone conferences or discussions with Governmental Authorities with respect to such Regulatory Filings; and (iv) all final clinical trial reports, in each case with respect to the Product Products and to the extent in existence as of the Signing Date;
(e) Until ownership of any Regulatory Filing is transferred to Company as set forth herein, Amgen is the owner of each such Regulatory Filing in the Field in the Territory;
(f) All the Product Lots provided to Company by Amgen pursuant to the Supply Agreement, as of the date each such Product Lot is provided to Company as set forth herein, have been manufactured, packaged, stored and labeled (as applicable) in accordance with cGMP and the specifications set forth in the Specifications ScheduleIntentionally omitted;
(g) As of the Signing Date, the copy of the Japan Agreement and each Pre-Existing Agreement disclosed to Company prior to the Signing Date is, but for the redactions contained therein, a true and complete copy. Amgen further represents and warrants that Company will not be bound by any provision that is redacted from such copies of the Japan Agreement and/or any Pre-Existing Agreement;; and [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(h) as of the Signing Date, [*], and (ii) [*]; and
(i) As of the Signing Date, Amgen has no knowledge that the manufacture of the Product Products using the Amgen Cell Line provided under this Agreement would infringe any patents of any Third PartyParty in a manner that would reasonably be expected to have a material adverse effect on Company’s ability to Commercialize the Products on or after January 1, 2019.
Appears in 3 contracts
Samples: Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.), Exclusive License Agreement (Atara Biotherapeutics, Inc.)
Additional Amgen Warranties. Amgen warrants to Company BioAge that, as of the Effective Date:
(a) As of the Signing Date, Amgen Controls has full legal or beneficial title and ownership to the Licensed Patents listed on Exhibit B as is necessary to grant the licenses to BioAge to such Licensed Patents that Amgen grants pursuant to this Agreement;
(b) The patents and patent applications listed on Exhibit B represent all Patent Rights Controlled by Amgen or its Affiliates that Cover the Licensed Compounds;
(c) Amgen has no actual knowledge (without making any inquiry) of any fact or circumstance that would affect the validity or enforceability of the Licensed Patents;
(d) Amgen has the rights necessary to grant the licenses to BioAge to Licensed Know-How listed on the Licensed Know-How Schedule, and is entitled that Amgen grants pursuant to grant the licenses specified herein. Amgen has not caused any this Agreement;
(e) The Patent Right Rights included in the Licensed Patents to be are not subject to any liens or encumbrances and Amgen has not granted to any Third Party any rights or licenses under such Patent Rights or Licensed Know-How that would conflict with the licenses granted to Company BioAge hereunder. None of No patent application or registration within the Licensed Patents are in-licensed by Amgenis the subject of any pending interference, opposition, cancellation or patent protest pursuant to 37 C.F.R. §1.291;
(bf) As of No Third Party has made any claim or allegation to Amgen or its Affiliates in writing that a Third Party has any right or interest in or to the Signing Date, Amgen has no Licensed Patents listed on Exhibit B; and
(g) To the knowledge of any Amgen, no claim or litigation that has been brought or threatened in writing by any Third Party alleging that (i) the Licensed Patents are invalid or unenforceable or (ii) the manufacture, sale, offer for sale sale, or importation of the Product in the Licensed Field in the Territory infringes or misappropriates or would infringe or misappropriate any patents or other intellectual property rights right of any Third Party; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(c) As of the Signing Date, no patent application or registration within the Licensed Patents is the subject of any pending interference, opposition, cancellation or patent protest pursuant to 37 C.F.R. § 1.291;
(d) Amgen has made available to Company true and correct copies of the following: (i) all material Regulatory Filings for the Territory; (ii) all material correspondence with Governmental Authorities with respect to such Regulatory Filings; (iii) all minutes of any material meetings, telephone conferences or discussions with Governmental Authorities with respect to such Regulatory Filings; and (iv) all final clinical trial reports, in each case with respect to the Product and to the extent in existence as of the Signing Date;
(e) Until ownership of any Regulatory Filing is transferred to Company as set forth herein, Amgen is the owner of each such Regulatory Filing in the Field in the Territory;
(f) All the Product Lots provided to Company by Amgen pursuant to the Supply Agreement, as of the date each such Product Lot is provided to Company as set forth herein, have been manufactured, packaged, stored and labeled (as applicable) in accordance with cGMP and the specifications set forth in the Specifications Schedule;
(g) As of the Signing Date, the copy of the Japan Agreement and each Pre-Existing Agreement disclosed to Company prior to the Signing Date is, but for the redactions contained therein, a true and complete copy. Amgen further represents and warrants that Company will not be bound by any provision that is redacted from such copies of the Japan Agreement and/or any Pre-Existing Agreement;
(h) as of the Signing Date, [*], and (ii) [*]; and
(i) As of the Signing Date, Amgen has no knowledge that the manufacture of the Product using the Amgen Cell Line provided under this Agreement would infringe any patents of any Third Party.
Appears in 2 contracts
Samples: Exclusive License Agreement (BioAge Labs, Inc.), Exclusive License Agreement (BioAge Labs, Inc.)
Additional Amgen Warranties. Amgen AMGEN warrants to Company RBNC that, as of the Execution Date and as of the Effective Date:
(a) As Neither AMGEN nor any of its Affiliates has (i) entered into an agreement granting any right, interest or claim in or to, any Licensed Patents or Exclusively Licensed Know-How to any Third Party; or (ii) transferred any of the Signing Date, Amgen Controls AMGEN Proprietary Licensed Compounds to a Third Party for Exploitation in the Licensed Patents Field in the Territory;
(b) AMGEN has full legal or beneficial title and ownership to the AMGEN Proprietary Licensed Compounds as is necessary to grant the licenses to RBNC to such AMGEN Proprietary Licensed Compounds that AMGEN grants pursuant to this Agreement;
(c) AMGEN has full legal or beneficial title and ownership to the Licensed Materials and to transfer the Licensed Materials under Section 2.5.1 to RBNC free and clear of all liens or other encumbrances;
(d) AMGEN has sufficient rights in and to the Licensed Know-How listed on to grant the licenses granted to RBNC under Article 2 of this Agreement;
(e) None of AMGEN, its Affiliates, any of its respective directors, officers, employees or any other Person employed or engaged by AMGEN (and its Affiliates) in any capacity in the discovery, research or development of the Licensed Compounds or in the development or manufacturing of the Licensed Materials has been debarred, suspended or excluded under United States Law, including under 21 U.S.C. § 335a and 42 U.S.C. § 1320a-7(a), any other Health Care Law or any foreign equivalent thereof, or has been the subject of debarment, suspension or exclusion proceedings by any Governmental Authority;
(f) To AMGEN’s knowledge, there is no infringement of any of the Licensed Patents as of the Execution Date;
(g) To AMGEN’s knowledge, there is no misappropriation of any of the Licensed Know-How Schedule, and is entitled to grant or Amgen Proprietary Licensed Compounds as of the licenses specified herein. Amgen has not caused any Patent Right included in the Execution Date;
(h) The Licensed Patents to be subject to any liens or encumbrances and Amgen has not granted to any Third Party any rights or licenses under such Patent Rights or Licensed Know-How constitutes all intellectual property Controlled by AMGEN and its Affiliates that would conflict with is necessary for the licenses granted to Company hereunder. None Exploitation of the Licensed Patents are inCompounds at their then-licensed by Amgencurrent stage of development as of the Effective Date;
(bi) As of the Signing Date, Amgen No Third Party has no knowledge of made any claim or allegation to AMGEN or its Affiliates in writing (i) that a Third Party has any right or interest in or to the Licensed Compounds or (ii) that any intellectual property right Controlled by a Third Party would be infringed or misappropriated by the Exploitation of the Licensed Compounds or Licensed Materials, in each case, as of the Execution Date; and
(j) To the knowledge of AMGEN’s patent litigation that attorneys, no claim or litigation has been brought or threatened in writing by any Third Party alleging that (i) the Licensed Patents are invalid or unenforceable or (ii) the manufacture, sale, offer for sale sale, or importation of the Product Licensed Compounds in the Licensed Field in the Territory infringes or misappropriates or would infringe or misappropriate any patents or other intellectual property rights right of any Third Party; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(c) As of the Signing Date, no patent application or registration within the Licensed Patents is the subject of any pending interference, opposition, cancellation or patent protest pursuant to 37 C.F.R. § 1.291;
(d) Amgen has made available to Company true and correct copies of the following: (i) all material Regulatory Filings for the Territory; (ii) all material correspondence with Governmental Authorities with respect to such Regulatory Filings; (iii) all minutes of any material meetings, telephone conferences or discussions with Governmental Authorities with respect to such Regulatory Filings; and (iv) all final clinical trial reports, in each case with respect to the Product and to the extent in existence Party as of the Signing Execution Date;
(e) Until ownership of any Regulatory Filing is transferred to Company as set forth herein, Amgen is the owner of each such Regulatory Filing in the Field in the Territory;
(f) All the Product Lots provided to Company by Amgen pursuant to the Supply Agreement, as of the date each such Product Lot is provided to Company as set forth herein, have been manufactured, packaged, stored and labeled (as applicable) in accordance with cGMP and the specifications set forth in the Specifications Schedule;
(g) As of the Signing Date, the copy of the Japan Agreement and each Pre-Existing Agreement disclosed to Company prior to the Signing Date is, but for the redactions contained therein, a true and complete copy. Amgen further represents and warrants that Company will not be bound by any provision that is redacted from such copies of the Japan Agreement and/or any Pre-Existing Agreement;
(h) as of the Signing Date, [*], and (ii) [*]; and
(i) As of the Signing Date, Amgen has no knowledge that the manufacture of the Product using the Amgen Cell Line provided under this Agreement would infringe any patents of any Third Party.
Appears in 2 contracts
Samples: Exclusive License Agreement (Neumora Therapeutics, Inc.), Exclusive License Agreement (Neumora Therapeutics, Inc.)
Additional Amgen Warranties. Amgen AMGEN warrants to Company RBNC that, as of the Execution Date and as of the Effective Date:
(a) As Neither AMGEN nor any of its Affiliates has (i) entered into an agreement granting any right, interest or claim in or to, any Licensed Patents or Exclusively Licensed Know-How to any Third Party; or (ii) transferred any of the Signing Date, Amgen Controls Licensed Compounds to a Third Party for Exploitation in the Licensed Patents Field in the Territory;
(b) AMGEN has full legal or beneficial title and ownership to the Licensed Compounds as is necessary to grant the licenses to RBNC to such Licensed Compounds that AMGEN grants pursuant to this Agreement;
(c) AMGEN has full legal or beneficial title and ownership to the Licensed Materials and to transfer the Licensed Materials under Section 2.5.1 to RBNC free and clear of all liens or other encumbrances;
(d) AMGEN has sufficient rights in and to the Licensed Know-How listed on to grant the licenses granted to RBNC under Article 2 of this Agreement;
(e) None of AMGEN, its Affiliates, any of its respective directors, officers, employees or any other Person employed or engaged by AMGEN (and its Affiliates) in any capacity in the discovery, research or development of the Licensed Compounds or in the development or manufacturing of the Licensed Materials has been debarred, suspended or excluded under United States Law, including under 21 U.S.C. § 335a and 42 U.S.C. § 1320a-7(a), any other Health Care Law or any foreign equivalent thereof, or has been the subject of debarment, suspension or exclusion proceedings by any Governmental Authority;
(f) To AMGEN’s knowledge, there is no infringement of any of the Licensed Patents as of the Execution Date;
(g) To AMGEN’s knowledge, there is no misappropriation of any of the Licensed Know-How Schedule, and is entitled to grant or Licensed Compounds as of the licenses specified herein. Amgen has not caused any Patent Right included in the Execution Date;
(h) The Licensed Patents to be subject to any liens or encumbrances and Amgen has not granted to any Third Party any rights or licenses under such Patent Rights or Licensed Know-How constitutes all intellectual property Controlled by AMGEN and its Affiliates that would conflict with is necessary for the licenses granted to Company hereunder. None Exploitation of the Licensed Patents are inCompounds at their then-licensed by Amgencurrent stage of development as of the Effective Date;
(bi) As of the Signing Date, Amgen No Third Party has no knowledge of made any claim or allegation to AMGEN or its Affiliates in writing (i) that a Third Party has any right or interest in or to the Licensed Compounds or (ii) that any intellectual property right Controlled by a Third Party would be infringed or misappropriated by the Exploitation of the Licensed Compounds or Licensed Materials, in each case, as of the Execution Date; and
(j) To the knowledge of AMGEN’s patent litigation that attorneys, no claim or litigation has been brought or threatened in writing by any Third Party alleging that (i) the Licensed Patents are invalid or unenforceable or (ii) the manufacture, sale, offer for sale sale, or importation of the Product Licensed Compounds in the Licensed Field in the Territory infringes or misappropriates or would infringe or misappropriate any patents or other intellectual property rights right of any Third Party; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(c) As of the Signing Date, no patent application or registration within the Licensed Patents is the subject of any pending interference, opposition, cancellation or patent protest pursuant to 37 C.F.R. § 1.291;
(d) Amgen has made available to Company true and correct copies of the following: (i) all material Regulatory Filings for the Territory; (ii) all material correspondence with Governmental Authorities with respect to such Regulatory Filings; (iii) all minutes of any material meetings, telephone conferences or discussions with Governmental Authorities with respect to such Regulatory Filings; and (iv) all final clinical trial reports, in each case with respect to the Product and to the extent in existence Party as of the Signing Execution Date;
(e) Until ownership of any Regulatory Filing is transferred to Company as set forth herein, Amgen is the owner of each such Regulatory Filing in the Field in the Territory;
(f) All the Product Lots provided to Company by Amgen pursuant to the Supply Agreement, as of the date each such Product Lot is provided to Company as set forth herein, have been manufactured, packaged, stored and labeled (as applicable) in accordance with cGMP and the specifications set forth in the Specifications Schedule;
(g) As of the Signing Date, the copy of the Japan Agreement and each Pre-Existing Agreement disclosed to Company prior to the Signing Date is, but for the redactions contained therein, a true and complete copy. Amgen further represents and warrants that Company will not be bound by any provision that is redacted from such copies of the Japan Agreement and/or any Pre-Existing Agreement;
(h) as of the Signing Date, [*], and (ii) [*]; and
(i) As of the Signing Date, Amgen has no knowledge that the manufacture of the Product using the Amgen Cell Line provided under this Agreement would infringe any patents of any Third Party.
Appears in 2 contracts
Samples: Exclusive License Agreement (Neumora Therapeutics, Inc.), Exclusive License Agreement (Neumora Therapeutics, Inc.)
Additional Amgen Warranties. Amgen AMGEN warrants to Company XXXXX that:, as of the Effective Date (except with respect to clause (f) below):
(a) As of the Signing Date, Amgen Controls AMGEN has full legal or beneficial title and ownership to the Licensed Patents and listed on Exhibit B as is necessary to grant the licenses to XXXXX to such Licensed Patents that AMGEN grants pursuant to this Agreement;
(b) AMGEN has the rights necessary to grant the licenses to XXXXX to Licensed Know-How listed on the Licensed Know-How Schedule, and is entitled that AMGEN grants pursuant to grant the licenses specified herein. Amgen has not caused any this Agreement;
(c) The Patent Right Rights included in the Licensed Patents to be are not subject to any liens or encumbrances and Amgen AMGEN has not granted to any Third Party any rights or licenses under such Patent Rights and has not granted to any Third Party any rights or licenses under such Licensed Know-How that would conflict with the licenses granted to Company hereunderXXXXX hereunder including, for clarity under any research or manufacturing agreements entered into by AMGEN with respect to the Licensed Compounds. None No patent application or registration within the Licensed Patents is the subject of any pending interference, opposition, cancellation or patent protest pursuant to 37 C.F.R. §1.291 or any foreign counterpart;
(d) No Third Party has made any claim or allegation to AMGEN or its Affiliates in writing that a Third Party has any right or interest in or to the Licensed Patents listed on Exhibit B; and
(e) To the knowledge of AMGEN’s patent litigation attorneys and patent attorneys involved in the prosecution or management of the Licensed Patents are in-licensed by Amgen;
(b) As of the Signing DatePatents, Amgen has no knowledge of any claim or litigation that has been brought or threatened in writing by any Third Party alleging that (i) the Licensed Patents are invalid or unenforceable or (ii) the manufacture, sale, offer for sale sale, or importation of the Licensed Product in the Licensed Field in the Territory infringes or misappropriates or would infringe or misappropriate any patents Patent Rights or other intellectual property rights right of any Third Party; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(c) As of the Signing Date, no patent application or registration within the Licensed Patents is the subject of any pending interference, opposition, cancellation or patent protest pursuant to 37 C.F.R. § 1.291;
(d) Amgen has made available to Company true and correct copies of the following: (i) all material Regulatory Filings for the Territory; (ii) all material correspondence with Governmental Authorities with respect to such Regulatory Filings; (iii) all minutes of any material meetings, telephone conferences or discussions with Governmental Authorities with respect to such Regulatory Filings; and (iv) all final clinical trial reports, in each case with respect to the Product and to the extent in existence as of the Signing Date;
(e) Until ownership of any Regulatory Filing is transferred to Company as set forth herein, Amgen is the owner of each such Regulatory Filing in the Field in the Territory;
(f) All The compounds listed on Exhibit D comprise all compounds that: (a) are Controlled by AMGEN or its Affiliates; (b)(1) for a monoclonal antibody, binds to TREM2 [***] and has agonist activity on TREM2 [***] and (2) for a small molecule, binds to TREM2 and has agonist activity on TREM2 [***]; and (c) were discovered, researched or developed in the Product Lots provided to Company conduct of the Licensed MAB Program or the Licensed Small Molecule Program by Amgen pursuant AMGEN or its Affiliates prior to the Supply Agreement, as of the date each such Product Lot is provided to Company as set forth herein, have been manufactured, packaged, stored and labeled (as applicable) in accordance with cGMP and the specifications set forth in the Specifications Schedule;Effective Date.
(g) As Exhibit A attached hereto lists a complete and accurate list of all final reports or electronic lab notebook entries for all completed preclinical studies related to the Signing Date, the copy Licensed Compounds conducted by or on behalf of the Japan Agreement AMGEN and each Pre-Existing Agreement disclosed to Company its Affiliates prior to the Signing Date is, but for the redactions contained therein, a true Effective Date. Such studies were conducted in accordance with applicable legal and complete copy. Amgen further represents and warrants that Company will not be bound by any provision that is redacted from such copies of the Japan Agreement and/or any Pre-Existing Agreement;professional standards.
(h) as As of the Signing Effective Date, [*]neither AMGEN, its Affiliates nor its respective employees, agents or contractors have employed or otherwise used in any capacity in connection with the development of the Licensed Compound the services of any Person debarred or excluded under United States Law, including under 21 U.S.C. § 335a and 42 U.S.C. § 1320a-7(a), or any foreign equivalent thereof, including any Person that has been: (i) debarred by the FDA (or subject to a similar sanction of a Regulatory Authority), or that is subject of an FDA debarment investigation or proceeding (or similar proceeding of a Regulatory Authority), or is otherwise ineligible to participate in federal healthcare programs or federal procurement or non-procurement programs; or (ii) [*]; and
(i) As has been convicted of a criminal offense that falls within the Signing Datescope of 42 U.S.C. § 1320a-7(a), Amgen but has no knowledge that the manufacture of the Product using the Amgen Cell Line provided under this Agreement would infringe any patents of any Third Partynot yet been excluded, debarred, suspended or otherwise declared ineligible.
Appears in 2 contracts
Samples: Exclusive License Agreement (Vigil Neuroscience, Inc.), Exclusive License Agreement (Vigil Neuroscience, Inc.)
Additional Amgen Warranties. Amgen AMGEN represents and warrants to Company JASPER that, as of the Effective Date:
(a) As AMGEN Controls and is the sole owner of the Signing Date, Amgen Controls the Licensed Patents and the Licensed Data and Controls the Licensed Non-Data Know-How, including the Licensed Non-Data Know-How listed on the Licensed Know-How ScheduleExhibit A, and is entitled to grant the licenses specified herein. Amgen Except with respect to the Stanford Agreement, (i) AMGEN has not caused any Patent Right included in the Licensed Patents to be subject to any liens or encumbrances encumbrances, and Amgen (ii) AMGEN has not granted to any Third Party any rights or licenses under such Patent Rights or Licensed Know-How that would conflict with the licenses granted to Company JASPER hereunder. None of the Licensed Patents or, to the knowledge of the employees of AMGEN and its Affiliates responsible for management of any day-to-day intellectual property, legal, or manufacturing/operations matters for the AMG 191 program, the Licensed Know-How are (A) in-licensed by Amgen;AMGEN, or (B) require a payment of the nature described by the “proviso” in Section 1.15.
(b) As Exhibit B sets forth a complete and accurate list of the Signing Patents Rights that are Controlled by AMGEN and its Affiliates, as of the Effective Date, Amgen that Cover the Exploitation of a Product in the Licensed Field. AMGEN does not Control any other Patent Rights that Covers a Product.
(c) […***…]. AMGEN has no knowledge of any claim or litigation that has been brought or threatened in writing by any Third Party alleging that (i) the Licensed Patents are invalid or unenforceable unenforceable.
(d) To Amgen’s knowledge, neither AMGEN nor any of its Affiliates employed or used the services of any Person, in connection with any activities relating to AMG 191, who was, at such time, debarred by the FDA (or subject to a similar sanction of a Regulatory Authority), or the subject of an FDA debarment investigation or proceeding (or similar proceeding of a Regulatory Authority). To Amgen’s knowledge, such activities were conducted by AMGEN and its Affiliates in accordance in all material respects with all applicable Laws.
(e) AMGEN and its Affiliates are not Exploiting, and currently have no plans to Exploit, any product (i) that comprises or contains […***…] or (ii) the manufacture, sale, offer for sale or importation of the Product use in the Field in the Territory infringes or misappropriates any patents or other intellectual property rights of any Third Party; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(c) As of the Signing Date, no patent application or registration within the Licensed Patents is the subject of any pending interference, opposition, cancellation or patent protest pursuant to 37 C.F.R. § 1.291;
(d) Amgen has made available to Company true and correct copies of the following: (i) all material Regulatory Filings for the Territory; (ii) all material correspondence with Governmental Authorities with respect to such Regulatory Filings; (iii) all minutes of any material meetings, telephone conferences or discussions with Governmental Authorities with respect to such Regulatory Filings; and (iv) all final clinical trial reports, in each case with respect to the Product and to the extent in existence as of the Signing Date;
(e) Until ownership of any Regulatory Filing is transferred to Company as set forth herein, Amgen is the owner of each such Regulatory Filing in the Field in the Territory;
(f) All the Product Lots provided to Company by Amgen pursuant to the Supply Agreement, as of the date each such Product Lot is provided to Company as set forth herein, have been manufactured, packaged, stored and labeled (as applicable) in accordance with cGMP and the specifications set forth in the Specifications Schedule;
(g) As of the Signing Date, the copy of the Japan Agreement and each Pre-Existing Agreement disclosed to Company prior to the Signing Date is, but for the redactions contained therein, a true and complete copy. Amgen further represents and warrants that Company will not be bound by any provision regimens that is redacted from such copies of the Japan Agreement and/or any Preintended to cause hematopoietic stem cell-Existing Agreement;
(h) as of the Signing Date, [*], and (ii) [*]; and
(i) As of the Signing Date, Amgen has no knowledge that the manufacture of the Product using the Amgen Cell Line provided under this Agreement would infringe any patents of any Third Partyclearing.
Appears in 1 contract
Samples: Exclusive License Agreement (Amplitude Healthcare Acquisition Corp)