DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to AbbVie’s retained rights to AbbVie Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture and commercialisation of the Licensed Products to be sold or supplied by the Licensee in the Territory under this Agreement. 3.2 Licensee will be solely responsible at its expense for making or having made all of its respective requirements for the Licensed Products in conformity with all applicable specifications in the Territory and will hold all relevant authorizations and permits required in this respect. 3.3 Licensee agrees that it will manufacture Licensed Compounds and Licensed Product in a manner consistent with (i) World Health Organization (“WHO”) pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority (“Stringent Regulatory Authority”), defined as regulatory authorities which are members, observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, as may be updated from time to time. Where such approvals are not yet available, the Licensee will obtain temporary approval through a WHO Expert Review Panel. 3.4 The Licensee will obtain from the relevant authorities in the Territory and maintain in force all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Licensed Products which are necessary to enable the Licensed Products to be sold or supplied in the Territory in accordance with this Agreement. Licensor and Licensee shall, as soon as practicable after the Effective Date, confer to agree upon reasonable milestones towards the registration of Licensed Products. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Licensed Products. 3.5 Within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide Licensor with a quarterly written report setting forth in relation to that Agreement Quarter (a) Licensed Products in its development pipeline, (b) status of development of each Licensed Product in development, (c) regulatory filing plan for each Licensed Product, and
Appears in 1 contract
Sources: License Agreement
DEVELOPMENT AND REGISTRATION. 3.1 4.1 As of the Effective Date and subject always to AbbVieViiV’s retained rights to AbbVie Patentsthe Patents and Non-Territory Patents (and that of its licensees), the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture and commercialisation of the Licensed Products to be sold or supplied by the Licensee in the Territory under this Agreement.
3.2 Licensee will be solely responsible at its expense for making or having made all of its respective requirements for the Licensed Products in conformity with all applicable specifications in the Territory and will hold all relevant authorizations and permits required in this respect.
3.3 4.2 Licensee agrees that it will manufacture Licensed Compounds Raw Materials and Licensed Product in a manner consistent with (i) World Health Organization (“WHO”) WHO pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority (“Stringent Regulatory Authority”"SRA"), defined as regulatory authorities which are members, observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, as may be updated from time to time. Where such approvals are not yet available, the Licensee will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable.
3.4 4.3 The Licensee will obtain from the relevant authorities in the Territory and maintain in force force, as appropriate, all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Licensed Products which are necessary to enable the Licensed Products to be sold or supplied in the Territory in accordance with this Agreement. Licensor and Licensee shallshall file for regulatory approval before at least one Relevant Regulatory Authority (including, as soon as practicable after but not limited to the WHO pre- qualification programme) not later than 30 months from the Effective Date, confer Date in respect to agree upon reasonable milestones towards the registration DTG Compound and not later than 36 months from the Effective Date in respect to at least one of Licensed the Products. The Licensee agreesshall also, where applicable and to upon Licensor’s reasonable request, file for regulatory approval before the extent that it is able: (a) to not seek; and (b) to waiveRelevant Regulatory Authority for any subsequent Products within a reasonable time.
4.4 If the Licensee sells, regulatory exclusivity supplies or otherwise disposes of any Product in the Territory in relation but has not obtained the necessary approvals pursuant to any data relating Clauses 4.2 and 4.3, the Licensor shall be entitled to immediately terminate this Agreement by providing written notice to the Licensed ProductsLicensee.
3.5 4.5 Within 10 ten (10) Business Days following the end of each Agreement Quarter, the Licensee shall provide the Licensor with a quarterly written report setting forth on the status of development of the Compound and any regulatory filing regarding the Products in relation to that Agreement Quarter Quarter. Such reporting shall be made in accordance with the Reporting Guidance issued by the Licensor and should cover (a) Licensed Products in its development pipeline, (b) status of development of each Licensed Product in development, (c) regulatory filing plan for each Licensed Product, andand (d) a list of countries for which such regulatory approvals or authorizations have been filed and/or obtained for any Product. The Parties agree to confer on a quarterly basis regarding such reports and also review development and filing status of Products. For avoidance of doubt, ▇▇▇▇ and the Licensor agree that information contained in quarterly and other such reports shall be treated as Confidential Information.
4.6 The Licensee will manufacture and sell the Products in accordance with all laws and regulations relevant to the manufacture and sale of the Products and in accordance with good industry practice.
4.7 Prior to engaging in any Development Activity, Licensee shall:
4.7.1 provide Licensor and ViiV with not less than one (1) month written notice of its intention to carry out such Development Activity;
4.7.2 meet with the Licensor and/or ViiV at such times and with such frequency as is reasonably requested by them to discuss the proposed activity; and
4.7.3 comply with the Licensor’s and ▇▇▇▇’s reasonable requests in relation to the design and conduct of such Development Activity.
Appears in 1 contract
Sources: Licensing Agreement
DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to AbbVie’s retained rights to AbbVie Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture and commercialisation of the Licensed Products to be sold or supplied by the Licensee in the Territory under this Agreement.
3.2 Licensee will be solely responsible at its expense for making or having made all of its respective requirements for the Licensed Products in conformity with all applicable specifications in the Territory and will hold all relevant authorizations and permits required in this respect.
3.3 Licensee agrees that it will manufacture Licensed Compounds and Licensed Product in a manner consistent with (i) World Health Organization (“WHO”) pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority (“Stringent Regulatory Authority”), defined as regulatory authorities which are members, observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, as may be updated from time to time. Where such approvals are not yet available, the Licensee will obtain temporary approval through a WHO Expert Review Panel.
3.4 The Licensee will obtain from the relevant authorities in the Territory and maintain in force all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Licensed Products which are necessary to enable the Licensed Products to be sold or supplied in the Territory in accordance with this Agreement. Licensee shall file for approval of a New Formulation before either the WHO pre- qualification programme or a Stringent Regulatory Authority not later than 20 months from the Effective Date in respect of the Licensed Compound and not later than 24 months from the Effective Date in respect to at least one New Formulation, and 42 months if human trials other than bioequivalence studies are required. Licensor and Licensee shall, as soon as practicable after the Effective Date, confer to agree upon reasonable milestones towards the development of a New Formulation in line with these registration of Licensed Productstimeframes. Licensee shall also, upon Licensor’s reasonable request, file for regulatory approval before the Relevant Regulatory Authority for any subsequent New Formulations within a reasonable time. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Licensed Products.
3.5 Within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide Licensor with a quarterly written report setting forth in relation to that Agreement Quarter (a) Licensed Products in its development pipeline, (b) status of development of each Licensed Product in development, (c) regulatory filing plan for each Licensed Product, andand (d) a list of countries within the Territory for which such regulatory approvals or authorizations have been filed or obtained for any Licensed Product. The Parties agree to meet on a quarterly basis regarding such reports and also review development and filing status of Licensed Products. Licensor agrees that information contained in quarterly and other such reports shall be treated as Confidential Information; provided, however, that such information may be shared with AbbVie (with AbbVie treating such reports as Confidential Information); and that aggregated data may be publicly disclosed by Licensor.
3.6 The Licensee will manufacture and sell the Licensed Products and Licensed Compounds in accordance with all laws and regulations relevant to the manufacture and sale of the Licensed Products and Licensed Compounds and in accordance with good industry practice.
Appears in 1 contract
Sources: License Agreement
DEVELOPMENT AND REGISTRATION. 3.1 4.1 As of the Effective Date and subject always to AbbVieViiV’s retained rights to AbbVie Patentsthe Patents and Non-Territory Patents (and those of its licensees), the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture and commercialisation of the Licensed Products to be sold or supplied by the Licensee in the Territory under this Agreement.
3.2 Licensee will be solely responsible at its expense for making or having made all of its respective requirements for the Licensed Products in conformity with all applicable specifications in the Territory and will hold all relevant authorizations and permits required in this respect.
3.3 4.2 The Licensee agrees that it will manufacture Licensed Compounds Raw Materials and Licensed Product in a manner consistent with (i) World Health Organization (“WHO”) WHO pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority (“Stringent Regulatory Authority”), defined as a regulatory authorities authority which are members, observers was a member or associates observer of the International Conference Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human UseUse (“ICH”), or associated with an ICH member through a legally-binding, mutual recognition agreement, in each case as may be updated from time to timebefore 23 October 2015. Where such approvals standards are not yet available, the Licensee will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable.
3.4 4.3 The Licensee will shall, or shall procure that its Approved Affiliate (if applicable) shall, obtain from the relevant authorities in each country of the Territory and maintain in force force, as appropriate, all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Licensed Products (including but not limited to Import Waivers where applicable) which are necessary to enable the Licensed Products to be sold or supplied in each country of the Territory in accordance with this Agreement. Licensor and The Licensee shallshall file, or procure that its Approved Affiliate files, for Regulatory Approval for a Licensed Mono Product before the Relevant Regulatory Authority in each country of the Territory as soon as practicable after possible and in any event not later than 12 months from the Effective Date, confer to agree upon reasonable milestones towards in each case using the registration fastest approval route possible.
4.4 If the Licensee sells, supplies or otherwise disposes of Licensed Products. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity any Product in the Territory in relation but has not obtained the necessary approvals pursuant to any data relating Clauses 4.2 and 4.3, the Licensor shall be entitled to immediately terminate this Agreement by providing written notice to the Licensed ProductsLicensee.
3.5 4.5 Within 10 ten (10) Business Days following the end of each Agreement Quarter, the Licensee shall provide the Licensor with a quarterly written report setting forth on all regulatory activities regarding the Products in the Territory in relation to that Agreement Quarter Quarter. Such reporting shall be made in accordance with the Reporting Guidance issued by the Licensor and shall cover (a) Licensed Products in its development pipeline, (b) status of development of each Licensed Product in development, (c) the regulatory filing plan for each Licensed every Product in the Territory, and (b) a list of the countries in the Territory in which applications for Regulatory Approval have been filed and/or Regulatory Approvals have been obtained for any Product. The Parties agree to confer on a quarterly basis regarding such reports and also review the filing status of Products. For avoidance of doubt, andViiV and the Licensor agree that information contained in quarterly and other such reports shall be treated as Confidential Information.
4.6 The Licensee will manufacture and sell the Products in accordance with all laws and regulations relevant to the manufacture and sale of the Products and in accordance with good industry practice.
4.7 Prior to engaging in any Development Activity, the Licensee shall: - provide the Licensor and ViiV with not less than one (1) month’s written notice of its intention to carry out such Development Activity; - meet with the Licensor and/or ViiV at such times and with such frequency as is reasonably requested by them to discuss the proposed activity; and - comply with the Licensor’s and ViiV’s reasonable requests in relation to the design and conduct of such Development Activity.
Appears in 1 contract
Sources: Licensing Agreement
DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to AbbVie’s retained rights to AbbVie Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture and commercialisation of the Licensed Products to be sold or supplied by the Licensee in the Territory under this Agreement.
3.2 Licensee will be solely responsible at its expense for making or having made all of its respective requirements for the Licensed Products in conformity with all applicable specifications in the Territory and will hold all relevant authorizations and permits required in this respect.respect.
3.3 Licensee agrees that it will manufacture Licensed Compounds and Licensed Product in a manner consistent with (i) World Health Organization (“WHO”) pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority (“Stringent Regulatory Authority”), defined as regulatory authorities which are members, observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, as may be updated from time to time. Where such approvals are not yet available, the Licensee will obtain temporary approval through a WHO Expert Review Panel.
3.4 The Licensee will obtain from the relevant authorities in the Territory and maintain in force all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Licensed Products which are necessary to enable the Licensed Products to be sold or supplied in the Territory in accordance with this Agreement. Licensee shall file for approval of a New Formulation before either the WHO pre- qualification programme or a Stringent Regulatory Authority not later than 20 months from the Effective Date in respect of the Licensed Compound and not later than 24 months from the Effective Date in respect to at least one New Formulation, and 42 months if human trials other than bioequivalence studies are required. Licensor and Licensee shall, as soon as practicable after the Effective Date, confer to agree upon reasonable milestones towards the development of a New Formulation in line with these registration of Licensed Productstimeframes. Licensee shall also, upon Licensor’s reasonable request, file for regulatory approval before the Relevant Regulatory Authority for any subsequent New Formulations within a reasonable time. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Licensed Products.
3.5 Within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide Licensor with a quarterly written report setting forth in relation to that Agreement Quarter (a) Licensed Products in its development pipeline, (b) status of development of each Licensed Product in development, (c) regulatory filing plan for each Licensed Product, andand (d) a list of countries within the Territory for which such regulatory approvals or authorizations have been filed or obtained for any Licensed Product. The Parties agree to meet on a quarterly basis regarding such reports and also review development and filing status of Licensed Products. Licensor agrees that information contained in quarterly and other such reports shall be treated as Confidential Information; provided, however, that such information may be shared with AbbVie (with AbbVie treating such reports as Confidential Information); and that aggregated data may be publicly disclosed by Licensor.
3.6 The Licensee will manufacture and sell the Licensed Products and Licensed Compounds in accordance with all laws and regulations relevant to the manufacture and sale of the Licensed Products and Licensed Compounds and in accordance with good industry practice.
Appears in 1 contract
Sources: License Agreement