Licensee Representations, Warranties and Covenants. Licensee hereby represents, warrants and covenants to Licensor as follows: (a) the execution, delivery and performance by Licensee of this Agreement and the consummation of the transactions contemplated hereby are within Licensee’s corporate powers and have been duly authorized by all necessary corporate action on the part of Licensee. This Agreement constitutes the legal, valid and binding obligation of Licensee, enforceable against Licensee in accordance with its terms; (b) Licensee will be at all times properly registered, licensed and qualified, and have all requisite power and authority under its organizational documents and in accordance with the Laws of the Territory to develop (including without limitation the conduct of clinical trials), promote, market, distribute, import, export and sell the Licensed Product in the Territory, and to conduct its business and perform its obligations hereunder and, during the Term, it shall take all action as may be required and necessary to obtain and keep current any governmental licenses, permits, registrations and approvals (including without limitation Regulatory Approvals) that are necessary or advisable for it to carry out its activities hereunder; (c) the execution, delivery and performance of this Agreement by Licensee will not violate any Law or any order of any Governmental Authority; (d) except for Regulatory Approvals and as may be required to permit the sale or importation of Licensed Product from time to time into the Territory during the Term, the execution, delivery or performance of this Agreement by Licensee will not require Licensee to obtain any permits, authorizations or consents from any Governmental Authority, and such execution, delivery and performance will not result in a material breach of or give rise to any termination of any agreement or contract to which Licensee is a Party; (e) Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) of the Generic Drug Enforcement Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) threatened to be debarred or (ii) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b) of the Generic Drug Enforcement Act of 1992 or similar Laws of any other jurisdiction. Licensee shall promptly notify Licensor upon learning of any such debarment, conviction, threat or indictment; (f) Licensee and its Affiliates and its and their respective employees, agents, contractors and consultants shall not use any Person on a Prohibited List in connection with the performance of any of its obligations or activities under this Agreement; (g) Licensee shall carry out its obligations and activities under this Agreement, including the development, promotion, marketing, distribution and sale of Licensed Products, in accordance with: (i) the terms hereof, (ii) all applicable Laws and Regulatory Laws, including without limitation the Pharmacy and Poisons Ordinance (Chapter 138 of the Laws of Hong Kong), the Dangerous Drugs Ordinance (Chapter 134 of the Laws of Hong Kong) and any subsidiary legislation thereunder; and (iii) GCP, GLP, and, to the extent Licensee manufactures or has manufactured any Licensed Products pursuant to Section 5.2 , GMP; (h) As of the Effective Date, Licensee believes in good faith that it will have sufficient financial resources available to carry out, or to have carried out, all of its obligations and activities contemplated under this Agreement; (i) Licensee and its Affiliates shall not develop, promote, market, distribute, or sell during the Initial Term and the Extended Term any product in the Field that utilizes or otherwise contains Tβ4 or any derivatives, analogs or fragments thereof without Licensor’s prior written approval, with the exception of peptide LKKTETQ that Licensee has licensed from the National Institute of Health of the United States of America prior to the signing of this Agreement. The development, promotion, marketing, distribution and sale of such peptide LKKTETQ by Licensee is subject to the provisions of 6.1(c); and (j) Licensee shall not reverse engineer or otherwise deconstruct any API or component part of finished Licensed Product for the purpose of developing a product that would compete with the Licensed Product in the Field.
Appears in 2 contracts
Samples: License Agreement (Regenerx Biopharmaceuticals Inc), License Agreement (Regenerx Biopharmaceuticals Inc)
Licensee Representations, Warranties and Covenants. Licensee hereby represents, warrants and covenants to Licensor as followsTXMD:
13.2.1 Licensee has the corporate power and authority and the legal right to bind all Affiliates to perform any Licensee obligations (to the extent performed by such Affiliates).
13.2.2 Licensee shall not, and shall cause its Affiliates and Sublicensees not to, (i) file an application for any Marketing Authorization or other Regulatory Approval relating to any Generic Product; (ii) purchase or otherwise acquire any such rights in any Generic Product and, to the extent that Licensee acquires such rights, it shall promptly divest the same, without prejudice to any rights or remedies that TXMD may have; or (iii) manufacture for another party any Generic Product.
13.2.3 Licensee, its Affiliates and its Sublicensees, (a) are not under investigation by the execution, delivery EMA or any other Regulatory Authority in the Territory for debarment or is not presently debarred (or subject to any similar penalty or restriction on its activities) by the EMA or any such other Regulatory Authority in any country or jurisdiction in the Territory pursuant to Applicable Law or by the rules and performance by Licensee of this Agreement and the consummation regulations of the transactions contemplated hereby are within Licensee’s corporate powers EMA or any such other Regulatory Authority, and have been duly authorized by all necessary corporate action on the part of Licensee. This Agreement constitutes the legal, valid and binding obligation of Licensee, enforceable against Licensee in accordance with its terms;
(b) Licensee will be at all times properly registered, licensed and qualified, and have all requisite power and authority under its organizational documents and not received written notice from the EMA or any such other Regulatory Authority in accordance with the Laws of any country or jurisdiction in the Territory of a pending disqualification hearing (or any similar hearing or proceeding) and has not been disqualified (or subject to develop (including without limitation any similar penalty or restriction on its activities) by the conduct of clinical trials), promote, market, distribute, import, export and sell the Licensed Product EMA or such other Regulatory Authority in any country or jurisdiction in the Territory, and to conduct its business and perform its obligations hereunder and. If, during the Term, it shall take all action as may be required and necessary to obtain and keep current any governmental licenses, permits, registrations and approvals (including without limitation Regulatory Approvals) that are necessary or advisable for it to carry out its activities hereunder;
(c) the execution, delivery and performance of this Agreement by Licensee will not violate any Law or any order of any Governmental Authority;
(d) except for Regulatory Approvals and as may be required to permit the sale or importation of Licensed Product from time to time into the Territory during the Term, the execution, delivery or performance of this Agreement by Licensee will not require Licensee to obtain any permits, authorizations or consents from any Governmental Authority, and such execution, delivery and performance will not result in a material breach of or give rise to any termination of any agreement or contract to which Licensee is a Party;
(e) Licensee, its Affiliates, and or any of its and their respective employees, agents, contractors and consultants have never been Sublicensees (i) debarred comes under investigation by the EMA or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) of by any other Regulatory Authority in any country or jurisdiction in the Generic Drug Enforcement Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) threatened to be debarred or (ii) indicted Territory for a crime debarment action or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) disqualification (or (b) of the Generic Drug Enforcement Act of 1992 any similar penalty or similar Laws of any other jurisdiction. Licensee shall promptly notify Licensor upon learning of any such debarment, conviction, threat or indictment;
(f) Licensee and restriction on its Affiliates and its and their respective employees, agents, contractors and consultants shall not use any Person on a Prohibited List in connection with the performance of any of its obligations or activities under this Agreement;
(g) Licensee shall carry out its obligations and activities under this Agreement, including the development, promotion, marketing, distribution and sale of Licensed Products, in accordance with: (i) the terms hereofactivities), (ii) all applicable Laws and Regulatory Laws, including without limitation the Pharmacy and Poisons Ordinance is debarred or disqualified (Chapter 138 of the Laws of Hong Kongor any similar penalty or restriction on its activities is imposed), the Dangerous Drugs Ordinance (Chapter 134 of the Laws of Hong Kong) and any subsidiary legislation thereunder; and or (iii) GCP, GLP, and, engages in any conduct or activity that could lead to the extent Licensee manufactures or has manufactured any Licensed Products pursuant to Section 5.2 , GMP;
(h) As of the Effective Dateabove-mentioned disqualification or debarment actions (or any similar penalty or restriction on its activities), Licensee believes in good faith that it will have sufficient financial resources available to carry out, or to have carried out, all shall immediately notify TXMD of its obligations and activities contemplated under this Agreement;
(i) Licensee and its Affiliates shall not develop, promote, market, distribute, or sell during the Initial Term and the Extended Term any product in the Field that utilizes or otherwise contains Tβ4 or any derivatives, analogs or fragments thereof without Licensor’s prior written approval, with the exception of peptide LKKTETQ that Licensee has licensed from the National Institute of Health of the United States of America prior to the signing of this Agreement. The development, promotion, marketing, distribution and sale of such peptide LKKTETQ by Licensee is subject to the provisions of 6.1(c); and
(j) Licensee shall not reverse engineer or otherwise deconstruct any API or component part of finished Licensed Product for the purpose of developing a product that would compete with the Licensed Product in the Fieldsame.
Appears in 1 contract
Samples: License and Supply Agreement (TherapeuticsMD, Inc.)
Licensee Representations, Warranties and Covenants. Licensee hereby represents, warrants and covenants to Licensor as follows:
(a) the execution, delivery and performance by Licensee of this Agreement and the consummation of the transactions contemplated hereby are within Licensee’s corporate powers and have been duly authorized by all necessary corporate action on the part of Licensee. This Agreement constitutes the legal, valid and binding obligation of Licensee, enforceable against Licensee in accordance with its terms;
(b) Licensee will be at all times properly registered, licensed and qualified, and have all requisite power and authority under its organizational documents and in accordance with the Laws of the Territory to develop (including without limitation the conduct of clinical trials), promote, market, distribute, import, export and sell the Licensed Product in the Territory, and to conduct its business and perform its obligations hereunder and, during the Term, it shall take all action as may be required and necessary to obtain and keep current any governmental licenses, permits, registrations and approvals (including without limitation Regulatory Approvals) that are necessary or advisable for it to carry out its activities hereunder;
(c) the execution, delivery and performance of this Agreement by Licensee will not violate any Law or any order of any Governmental Authority;
(d) except for Regulatory Approvals and as may be required to permit the sale or importation of Licensed Product from time to time into the Territory during the Term, the execution, delivery or performance of this Agreement by Licensee will not require Licensee to obtain any permits, authorizations or consents from any Governmental Authority, and such execution, delivery and performance will not result in a material breach of or give rise to any termination of any agreement or contract to which Licensee is a Party;
(e) Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) of the Generic Drug Enforcement Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) threatened to be debarred or (ii) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b) of the Generic Drug Enforcement Act of 1992 or similar Laws of any other jurisdiction. Licensee shall promptly notify Licensor upon learning of any such debarment, conviction, threat or indictment;
(f) Licensee and its Affiliates and its and their respective employees, agents, contractors and consultants shall not use any Person on a Prohibited List in connection with the performance of any of its obligations or activities under this Agreement;
(g) Licensee shall carry out its obligations and activities under this Agreement, including the development, promotion, marketing, distribution and sale of Licensed Products, in accordance with: (i) the terms hereof, (ii) all applicable Laws and Regulatory Laws, including without limitation the Pharmacy and Poisons Ordinance (Chapter 138 of the Laws of Hong Kong), the Dangerous Drugs Ordinance (Chapter 134 of the Laws of Hong Kong) and any subsidiary legislation thereunder; and (iii) GCP, GLP, and, to the extent Licensee manufactures or has manufactured any Licensed Products pursuant to Section 5.2 , GMP;
(h) As of the Effective Date, Licensee believes in good faith that it will have sufficient financial resources available to carry out, or to have carried out, all of its obligations and activities contemplated under this Agreement;
(i) Licensee and its Affiliates shall not develop, promote, market, distribute, or sell during the Initial Term and the Extended Term any product in the Field that utilizes or otherwise contains Tβ4 or any derivatives, analogs or fragments thereof without Licensor’s prior written approval, with the exception of peptide LKKTETQ that Licensee has licensed from the National Institute of Health of the United States of America prior to the signing of this Agreement. The development, promotion, marketing, distribution and sale of such peptide LKKTETQ by Licensee is subject to the provisions of 6.1(c); and
(j) Licensee shall not reverse engineer or otherwise deconstruct any API or component part of finished Licensed Product for the purpose of developing a product that would compete with the Licensed Product in the Field.
Appears in 1 contract
Samples: License Agreement (Regenerx Biopharmaceuticals Inc)
Licensee Representations, Warranties and Covenants. Licensee hereby represents, warrants and covenants to Licensor as follows:
(a) the execution, delivery and performance by Licensee of this Agreement and the consummation of the transactions contemplated hereby are within Licensee’s corporate powers and have been duly authorized by all necessary corporate action on the part of Licensee. This Agreement constitutes the legal, valid and binding obligation of Licensee, enforceable against Licensee in accordance with its terms;
(b) Licensee will be at all times properly registered, licensed and qualified, and have all requisite power and authority under its organizational documents and in accordance with the Laws of the Territory to develop (including without limitation the conduct of clinical trials), promote, market, distribute, import, export and sell the Licensed Product in the Territory, and to conduct its business and perform its obligations hereunder and, during the Term, it shall take all action as may be required and necessary to obtain and keep current any governmental licenses, permits, registrations and approvals (including without limitation Regulatory Approvals) that are necessary or advisable for it to carry out its activities hereunder;
(c) the execution, delivery and performance of this Agreement by Licensee will not violate any Law or any order of any Governmental Authority;
(d) except for Regulatory Approvals and as may be required to permit the sale or importation of Licensed Product from time to time into the Territory during the Term, the execution, delivery or performance of this Agreement by Licensee will not require Licensee to obtain any permits, authorizations or consents from any Governmental Authority, and such execution, delivery and performance will not result in a material breach of or give rise to any termination of any agreement or contract to which Licensee is a Party;
(e) Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) of the Generic Drug Enforcement Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) threatened to be debarred or (ii) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b) of the Generic Drug Enforcement Act of 1992 or similar Laws of any other jurisdiction. Licensee shall promptly notify Licensor upon learning of any such debarment, conviction, threat or indictment;
(f) Licensee and its Affiliates and its and their respective employees, agents, contractors and consultants shall not use any Person on a Prohibited List in connection with the performance of any of its obligations or activities under this Agreement;
(g) Licensee shall carry out its obligations and activities under this Agreement, including the development, promotion, marketing, distribution and sale of Licensed Products, in accordance with: (i) the terms hereof, (ii) all applicable Laws and Regulatory Laws, including without limitation the Pharmacy and Poisons Ordinance (Chapter 138 of the Laws of Hong Kong), the Dangerous Drugs Ordinance (Chapter 134 of the Laws of Hong Kong) and any subsidiary legislation thereunder; and (iii) GCP, GLP, and, to the extent Licensee manufactures or has manufactured any Licensed Products pursuant to Section 5.2 , GMP;
(h) As of the Effective Date, all written declarations made, directly or indirectly, by Licensee believes to Licensor related to Licensee’s qualifications, ability and competence to Develop and Commercialize the Licensed Products in the Territory are true and correct.
(b) As of the Effective Date and at any time during the Term, Licensee (i) shall have and maintain facilities, personnel, experience and expertise sufficient in quality and quantity to perform its obligations hereunder (including through subcontractors or Sublicensees), (ii) shall perform its obligations hereunder with reasonable due care and in conformity with current generally accepted industry standards and procedures and (iii) shall procure that its management establishes and maintains appropriate quality assurance, quality controls and review procedures to secure good faith that it will have sufficient financial resources available to carry out, or to have carried out, all standard performance of its obligations hereunder.
(c) As of the Effective Date and at any time during the Term, Licensee will procure that all data related to human samples and other Personal Data obtained in course of the Development, Manufacturing or Commercialization of a Compound or a Licensed Product will be obtained, processed and stored in compliance with Applicable Laws, including applicable Data Protection Law, in all material respects. In particular, to the extent applicable to the activities contemplated under to be conducted by this Agreement;Agreement and required by Applicable Law, the signature of the informed consent from the donor will be obtained, the confidentiality and anonymization of the human samples will be procured and the personnel involved in such activities will be authorized and will have the capacity to perform such activities, in each case, in all material respects.
(d) As of the Effective Date and at any time during the Term, Licensee will comply with all Applicable Laws for the care, welfare and ethical treatment of animals in the country where the Development is being performed. In order to ensure proper treatment and use of animals, Licensee will adhere at a minimum to (i) Licensee Licensor’s policy on the use, care and its Affiliates shall not developwelfare of laboratory animals, promote(ii) Licensor Standard on “Housing and Husbandry Practices for Common Laboratory Animals”, market(iii) the principle of “3Rs” – reduction, distributerefinement and replacement of animal studies; (iv) the principle to offer state of the art housing and husbandry conditions in the care and use of animals which means access to species appropriate food and water; access to species specific housing, or sell including species appropriate temperature and humidity levels; access to humane care and a program of veterinary care; animal housing that minimizes the development of abnormal behaviors; review of study design and purpose by institutional ethical review panel; commitment to minimizing pain and distress during the Initial Term studies conducted under the research plan and the Extended Term any product work is performed by demonstrable trained staff; provided that in the Field that utilizes or otherwise contains Tβ4 or any derivativeseach case of clauses (i)–(iv) such policies, analogs or fragments thereof without Licensor’s prior written approval, with the exception of peptide LKKTETQ that standards and principles have been provided to Licensee has licensed from the National Institute of Health of the United States of America in writing prior to the signing of this Agreement. The development, promotion, marketing, distribution and sale of such peptide LKKTETQ by Licensee is subject to the provisions of 6.1(c); and
(j) Licensee shall not reverse engineer or otherwise deconstruct any API or component part of finished Licensed Product for the purpose of developing a product that would compete with the Licensed Product in the FieldEffective Date.
Appears in 1 contract
Licensee Representations, Warranties and Covenants. Licensee hereby representsrepresents and warrants to Bioeq as of the Effective Date and covenants, warrants and covenants to Licensor as followsapplicable, that:
(a) 12.3.1 Licensee has the execution, delivery right to grant the licenses and performance by Licensee of rights it purports to grant pursuant to this Agreement and the consummation of the transactions contemplated hereby are within Licensee’s corporate powers and have been duly authorized by all necessary corporate action on the part of Licensee. This Agreement constitutes the legal, valid and binding obligation of Licensee, enforceable against Licensee in accordance with its terms;Agreement.
(b) 12.3.2 [***]
12.3.3 [***]
12.3.4 [***]
12.3.5 Licensee will be at all times properly registered, licensed maintain (and qualified, will use Commercially Reasonable Efforts to cause its suppliers and have all requisite power CMOs to maintain) appropriate skilled personnel and authority under its organizational documents and in accordance with the Laws of the Territory to develop (including without limitation the conduct of clinical trials), promote, market, distribute, import, export and sell the Licensed Product in the Territory, and to conduct its business and perform its obligations hereunder and, during the Term, it shall take all action as may be required and necessary to obtain and keep current any governmental licenses, permits, registrations and approvals (including without limitation Regulatory Approvals) that are necessary or advisable for it facilities to carry out its activities hereunder;obligations under this Agreement.
12.3.6 Licensee will ensure that the information contained within all submissions to, and filings, correspondence, and communications with Regulatory Authorities made by or on behalf of Licensee or its Affiliates with respect to the Licensed Product (c[***]) the executionwill be, delivery to Licensee’s knowledge, true and performance of this Agreement by accurate in all material aspects and will be generated in compliance with Applicable Law.
12.3.7 Licensee will not violate use any Law employees or any order other persons performing services on behalf of any Governmental Authority;
(d) except for Regulatory Approvals and as may be required Licensee in relation to permit the sale Development, Manufacture, or importation Commercialization of Licensed Product from time to time into the Territory during the Term, the execution, delivery or performance of this Agreement by Licensee will not require Licensee to obtain any permits, authorizations or consents from any Governmental Authority, and such execution, delivery and performance will not result in a material breach of or give rise to any termination of any agreement or contract to which Licensee is a Party;
(e) Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants Products that have never been (i) debarred or (ii) convicted excluded, or are the subject of a crime for which debarment or exclusion proceedings; and if Licensee becomes aware that a person can be debarredperforming on its behalf in relation to the Development, under Section 306(a) Manufacture, or Commercialization of the Generic Drug Enforcement Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never Licensed Products has been (i) threatened to be debarred or (ii) indicted for a crime excluded, or otherwise engaged in conduct for which a person can be debarredhas become the subject of debarment or exclusion proceedings, under Section 306(a) or (b) of the Generic Drug Enforcement Act of 1992 or similar Laws of any other jurisdiction. Licensee shall promptly notify Licensor upon learning of any Bioeq and shall prohibit such debarment, conviction, threat or indictment;
(f) Licensee and person from performing such activities on its Affiliates and its and their respective employees, agents, contractors and consultants shall not use any Person on a Prohibited List in connection with the performance of any of its obligations or activities behalf under this Agreement;
(g) Licensee shall carry out its obligations and activities under this Agreement, including the development, promotion, marketing, distribution and sale of Licensed Products, in accordance with: (i) the terms hereof, (ii) all applicable Laws and Regulatory Laws, including without limitation the Pharmacy and Poisons Ordinance (Chapter 138 of the Laws of Hong Kong), the Dangerous Drugs Ordinance (Chapter 134 of the Laws of Hong Kong) and any subsidiary legislation thereunder; and (iii) GCP, GLP, and, to the extent Licensee manufactures or has manufactured any Licensed Products pursuant to Section 5.2 , GMP;
(h) As of the Effective Date, Licensee believes in good faith that it will have sufficient financial resources available to carry out, or to have carried out, all of its obligations and activities contemplated under this Agreement;
(i) Licensee and its Affiliates shall not develop, promote, market, distribute, or sell during the Initial Term and the Extended Term any product in the Field that utilizes or otherwise contains Tβ4 or any derivatives, analogs or fragments thereof without Licensor’s prior written approval, with the exception of peptide LKKTETQ that Licensee has licensed from the National Institute of Health of the United States of America prior to the signing of this Agreement. The development, promotion, marketing, distribution and sale of such peptide LKKTETQ by Licensee is subject to the provisions of 6.1(c); and
(j) Licensee shall not reverse engineer or otherwise deconstruct any API or component part of finished Licensed Product for the purpose of developing a product that would compete with the Licensed Product in the Field.
Appears in 1 contract
Samples: License and Development Agreement (Coherus BioSciences, Inc.)
Licensee Representations, Warranties and Covenants. Licensee hereby represents, represents and warrants and covenants to Licensor as follows:
(a) During the execution, delivery and performance by Licensee term of this Agreement and any renewal thereof, Licensee will hold all licenses and other permits and authorizations necessary for the consummation operation of the transactions contemplated hereby Station, and such licenses, permits and authorizations are within and will be in full force and effect throughout the term of this Agreement and any renewal thereof. There is not pending, or to Licensee’s corporate powers and have been duly authorized 's best knowledge, threatened, any action by all necessary corporate action on the part FCC or by any other party to revoke, cancel, suspend, refuse to renew or modify adversely any of such licenses, permits or authorizations. To the best of Licensee. This Agreement constitutes 's knowledge, Licensee is not in violation of any statute, ordinance, rule, regulation, policy, order or decree of any federal, state or local entity, court or authority having jurisdiction over it or the legalStation, valid and binding obligation of which would have an adverse effect upon the Licensee, enforceable against its assets, the Station or upon Licensee's ability to perform this Agreement. Licensee shall not take any action or omit to take any action which would have an adverse impact upon the Licensee, its assets, the Station or upon Licensee's ability to perform this Agreement. All reports and applications required to be filed with the FCC or any other governmental body during the course of the initial term of this Agreement or any renewal thereof, will be filed in a timely and complete manner. The facilities of the Station will be maintained in accordance with good engineering practice and will comply in all material respects with the engineering requirements set forth in the FCC authorizations, permits and licenses for the Station, and Licensee will ensure that the Station broadcasts a high quality signal to its terms;service area (except at such time where reduction of power is required for routine or emergency maintenance). Licensee, throughout the term of this Agreement and any renewal thereof, will maintain good and marketable title to all of the assets and properties used and useful in the operation of the Station. During the term of this Agreement and any renewal thereof, Licensee shall not dispose of, transfer, assign or pledge any of such assets and properties except with the prior written consent of the Programmer, if such action would adversely affect Licensee's performance hereunder or the business and
(b) Licensee will be at all times properly registeredshall pay, licensed and qualified, and have all requisite power and authority under its organizational documents and in accordance with the Laws of the Territory to develop (including without limitation the conduct of clinical trials), promote, market, distribute, import, export and sell the Licensed Product in the Territory, and to conduct its business and perform its obligations hereunder and, during the Term, it shall take all action as may be required and necessary to obtain and keep current any governmental licenses, permits, registrations and approvals (including without limitation Regulatory Approvals) that are necessary or advisable for it to carry out its activities hereunder;
(c) the execution, delivery and performance of this Agreement by Licensee will not violate any Law or any order of any Governmental Authority;
(d) except for Regulatory Approvals and as may be required to permit the sale or importation of Licensed Product from time to time into the Territory during the Term, the execution, delivery or performance of this Agreement by Licensee will not require Licensee to obtain any permits, authorizations or consents from any Governmental Authority, and such execution, delivery and performance will not result in a material breach of or give rise to any termination of any agreement or contract to which Licensee is a Party;
(e) Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) of the Generic Drug Enforcement Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) threatened to be debarred or (ii) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b) of the Generic Drug Enforcement Act of 1992 or similar Laws of any other jurisdiction. Licensee shall promptly notify Licensor upon learning of any such debarment, conviction, threat or indictment;
(f) Licensee and its Affiliates and its and their respective employees, agents, contractors and consultants shall not use any Person on a Prohibited List in connection with the performance of any of its obligations or activities under this Agreement;
(g) Licensee shall carry out its obligations and activities under this Agreement, including the development, promotion, marketing, distribution and sale of Licensed Products, in accordance with: (i) the terms hereof, (ii) all applicable Laws and Regulatory Laws, including without limitation the Pharmacy and Poisons Ordinance (Chapter 138 of the Laws of Hong Kong), the Dangerous Drugs Ordinance (Chapter 134 of the Laws of Hong Kong) and any subsidiary legislation thereunder; and (iii) GCP, GLP, and, to the extent Licensee manufactures or has manufactured any Licensed Products pursuant to Section 5.2 , GMP;
(h) As of the Effective Date, Licensee believes in good faith that it will have sufficient financial resources available to carry out, or to have carried outtimely fashion, all of its obligations the expenses incurred in operating the Station including lease payments, utilities, taxes, etc., as set forth in Attachment 1.5, and activities contemplated under this Agreement;
shall provide Programmer with a certificate of such timely payment within thirty (i30) Licensee and its Affiliates shall not develop, promote, market, distribute, or sell during the Initial Term and the Extended Term any product in the Field that utilizes or otherwise contains Tβ4 or any derivatives, analogs or fragments thereof without Licensor’s prior written approval, with the exception of peptide LKKTETQ that Licensee has licensed from the National Institute of Health days of the United States end of America prior to the signing of this Agreement. The development, promotion, marketing, distribution and sale of such peptide LKKTETQ by Licensee is subject to the provisions of 6.1(c); and
(j) Licensee shall not reverse engineer or otherwise deconstruct any API or component part of finished Licensed Product for the purpose of developing a product that would compete with the Licensed Product in the Fieldeach month.
Appears in 1 contract
Samples: Time Brokerage Agreement (Sinclair Broadcast Group Inc)
Licensee Representations, Warranties and Covenants. Licensee hereby represents, warrants and covenants to Licensor as follows:
(a) the execution, delivery and performance by Licensee of this Agreement and the consummation of the transactions contemplated hereby are within Licensee’s corporate powers and have been duly authorized by all necessary corporate action on the part of Licensee. This Agreement constitutes the legal, valid and binding obligation of Licensee, enforceable against Licensee in accordance with its terms;
(b) Licensee will be at all times properly registered, licensed and qualified, and have all requisite power and authority under its organizational documents and in accordance with the Laws of the Territory to develop (including without limitation the conduct of clinical trials), promote, market, distribute, import, export and sell the Licensed Product in the Territory, and to conduct its business and perform its obligations hereunder and, during the Term, it shall take all action as may be required and necessary to obtain and keep current any governmental licenses, permits, registrations and approvals (including without limitation Regulatory Approvals) that are necessary or advisable for it to carry out its activities hereunder;
(c) the execution, delivery and performance of this Agreement by Licensee will not violate any Law or any order of any Governmental Authority;
(d) except for Regulatory Approvals and as may be required to permit the sale or importation of Licensed Product from time to time into the Territory during the Term, the execution, delivery or performance of this Agreement by Licensee will not require Licensee to obtain any permits, authorizations or consents from any Governmental Authority, and such execution, delivery and performance will not result in a material breach of or give rise to any termination of any agreement or contract to which Licensee is a Party;
(e) Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) of the Generic Drug Enforcement Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) threatened to be debarred or (ii) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b) of the Generic Drug Enforcement Act of 1992 or similar Laws of any other jurisdiction. Licensee shall promptly notify Licensor upon learning of any such debarment, conviction, threat or indictment;
(f) Licensee and its Affiliates and its and their respective employees, agents, contractors and consultants shall not use any Person on a Prohibited List in connection with the performance of any of its obligations or activities under this Agreement;
(g) Licensee shall carry out its obligations and activities under this Agreement, including the development, promotion, marketing, distribution and sale of Licensed Products, in accordance with: (i) the terms hereof, (ii) all applicable Laws and Regulatory Laws, including without limitation the Pharmacy and Poisons Ordinance (Chapter 138 of the Laws of Hong Kong), the Dangerous Drugs Ordinance (Chapter 134 of the Laws of Hong Kong) and any subsidiary legislation thereunder; and (iii) GCP, GLP, and, to the extent Licensee manufactures or has manufactured any Licensed Products pursuant to Section 5.2 , GLP and GMP;; INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
(h) As of the Effective Date, Licensee believes in good faith that it will have sufficient financial resources available to carry out, or to have carried out, all of its obligations and activities contemplated under this Agreement;
(i) Licensee and its Affiliates shall not develop, promote, market, distribute, or sell during the Initial Term and the Extended Term any product in the Field Field, EXCEPT as authorized, permitted, or agreed otherwise herein, that utilizes or otherwise contains Tβ4 or any derivatives, analogs or fragments thereof without Licensor’s prior written approval, with the exception of peptide LKKTETQ that Licensee has licensed from the National Institute of Health of the United States of America prior to the signing of this Agreement. The development, promotion, marketing, distribution and sale of such peptide LKKTETQ by Licensee is subject to the provisions of 6.1(c); and
(j) Licensee shall not reverse engineer or otherwise deconstruct any API or component part of finished Licensed Product for the purpose of developing a product that would compete with the Licensed Product in the Field.
Appears in 1 contract
Samples: License Agreement (Regenerx Biopharmaceuticals Inc)
Licensee Representations, Warranties and Covenants. Licensee hereby represents, warrants and covenants to Licensor as follows:
(a) the execution, delivery and performance by Licensee of this Agreement by Licensee and the consummation of the transactions contemplated hereby are within the Licensee’s corporate powers and have been duly authorized by all necessary corporate action on the part of Licensee. This Agreement constitutes the legal, valid and binding obligation obligations of the Licensee, enforceable against the Licensee in accordance with its terms;
(b) Licensee will be at all times properly registered, licensed and qualified, and have all requisite power and authority under its organizational documents and in accordance with the applicable Laws of the Territory to develop (including without limitation the conduct of clinical trials), promote, market, distribute, import, export market and sell the Licensed Product in the Territory, and to conduct its business and perform its obligations hereunder and, during the TermTerm and any extensions thereof, it shall take all action as may be required and necessary to obtain and keep current any governmental licenses, permits, registrations and approvals (including without limitation Regulatory Approvals) that are necessary or advisable for it to develop, make, market and sell the Licensed Product and carry out its other activities hereunder;
(c) the execution, delivery and performance of this Agreement by Licensee will not violate violate: (i) any Law Laws or any order of any Governmental or Regulatory Authority; or (ii) any provision of Licensee’s certificate of incorporation or other organizational documents;
(d) except for Regulatory Approvals Licensee shall carry out its obligations and as may be required to permit the sale or importation of Licensed Product from time to time into the Territory during the Term, the execution, delivery or performance of activities under this Agreement by Licensee will not require Licensee to obtain any permits(including without limitation the marketing, authorizations or consents from any Governmental Authoritypromotion, distribution and such execution, delivery sale of the Licensed Product) in accordance with: (i) the terms hereof and performance will not result in a material breach of or give rise to any termination of any agreement or contract to which Licensee is a Party;(ii) all applicable Laws; and
(e) Licensee, its Affiliates, Licensee and its and their respective employees, agents, contractors and consultants employees have never been (i) debarred or (ii) convicted of a crime for which a person Person can be debarred, debarred under Section 306(a) of the U.S. Generic Drug Enforcement Act of 1992 (Section 306 (a) or (b)) or similar Laws of any foreign jurisdiction. Licensee, its Affiliates, and its and their respective employees, agents, contractors and consultants have never been (i) threatened to be debarred or (ii) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b) of the Generic Drug Enforcement Act of 1992 or similar Laws of any other jurisdiction. Licensee shall promptly notify Licensor upon learning of any such debarment, conviction, threat or indictment;
(f) Licensee and its Affiliates and its and their respective employees, agents, contractors and consultants shall not use any Person on a Prohibited List in connection with the performance of any of its obligations or activities under this Agreement;
(g) Licensee shall carry out its obligations and activities under this Agreement, including the development, promotion, marketing, distribution and sale of Licensed Products, in accordance with: (i) the terms hereof, (ii) all applicable Laws and Regulatory Laws, including without limitation the Pharmacy and Poisons Ordinance (Chapter 138 of the Laws of Hong Kong), the Dangerous Drugs Ordinance (Chapter 134 of the Laws of Hong Kong) and any subsidiary legislation thereunder; and (iii) GCP, GLP, and, to the extent Licensee manufactures or has manufactured any Licensed Products pursuant to Section 5.2 , GMP;
(h) As of the Effective Date, Licensee believes in good faith that it will have sufficient financial resources available to carry out, or to have carried out, all of its obligations and activities contemplated under this Agreement;
(i) Licensee and its Affiliates shall not develop, promote, market, distribute, or sell during the Initial Term and the Extended Term any product in the Field that utilizes or otherwise contains Tβ4 or any derivatives, analogs or fragments thereof without Licensor’s prior written approval, with the exception of peptide LKKTETQ that Licensee has licensed from the National Institute of Health of the United States of America prior to the signing of this Agreement. The development, promotion, marketing, distribution and sale of such peptide LKKTETQ by Licensee is subject to the provisions of 6.1(c); and
(j) Licensee shall not reverse engineer or otherwise deconstruct any API or component part of finished Licensed Product for the purpose of developing a product that would compete with the Licensed Product in the Field.
Appears in 1 contract
Samples: Exclusive License Agreement (CASI Pharmaceuticals, Inc.)