DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to MSD's retained rights to the Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture, and commercialisation of the Products to be sold or supplied by the Licensee in the Territory under this Agreement.
3.2 Licensee agrees that it will manufacture the Substance and the Product in a manner consistent with (i) WHO Pre-qualification standards; or (ii) the standards of any SRA. Licensee will not sell any Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA, and will comply with applicable regulatory requirements in the country of manufacturing and the country of sale.
3.3 Licensee shall submit a complete file for WHO Pre-qualification or any SRA approval within 36 months from the Effective Date for any existing formulation of the Products, or within a period to be agreed among MSD, MPP and Licensee for any new formulation of the Product. Licensee will diligently pursue such applications following submission. 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 Products.
3.4 For the period beginning from the Effective Date, within 10 Business Days following the end of each Agreement Quarter, Licensee shall provide MPP with a quarterly written report covering all its activities related to the development and testing of all Products and/or Substance (as permitted and to the extent applicable) and the obtaining of necessary governmental approvals; these shall include (but is not limited and to the extent applicable and permitted) to its (a) Products and/or Substance in its development pipeline, (b) status of development of each Product and/or Substance in development,
DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to ViiV’s retained rights to the Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture and commercialisation of the Products to be sold or supplied by the Licensee in the Territory under this Agreement.
3.2 Licensee agrees that it will manufacture Raw Materials and Product in a manner consistent with (i) World Health Organization ("WHO") pre-qualification standards; or (ii) the standards of any 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.
3.3 The Licensee will obtain from the relevant authorities in the Territory and maintain in force, as appropriate, all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Products which are necessary to enable the Products to be sold or supplied in the Territory in accordance with this Agreement.
3.4 If the Licensee sells, supplies or otherwise disposes of any Product in the Territory but has not obtained the necessary approvals pursuant to Clauses 3.2 and 3.3, the Licensor shall be entitled to immediately terminate this Agreement by providing written notice to the Licensee.
3.5 Licensee shall provide Licensor with a quarterly written report setting forth (a) Products in its development pipeline, (b) status of development of each Product in development, (c) regulatory filing plan for each Product, and (d) a list of countries within the Territory for which such regulatory approvals or authorizations have been obtained for any Product. The Parties agree to confer on a quarterly basis regarding such reports. For avoidance of doubt, ViiV and the Licensor agree that information contained in quarterly and other such reports shall be treated as Confidential Information.
3.6 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.
DEVELOPMENT AND REGISTRATION. 4.1. The Sublicensee agrees that it will manufacture Materials and Product in a manner consistent with (i) WHO pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority, defined as a regulatory authority which was a member or observer of the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”), or associated with an ICH member through a legally-binding, mutual recognition agreement, in each case as before 23 October 2015. Where such standards are not yet available, the Sublicensee will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable.
4.2. The Sublicensee shall:
A. obtain from the relevant authorities in each country and maintain in force, as appropriate, all health registrations, permissions, consents and regulatory authorisations relating to the importation, manufacture and sale of the Products which are necessary to enable the Products to be sold or supplied in each country in accordance with this Agreement.
B. file for WHO Pre-qualification or any Stringent Regulatory Authority approval as soon as possible and in any event not later than within 24 months from the Effective Date in each case using the fastest approval route possible and will diligently pursue such applications following submission.
C. 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.
4.3. If the Sublicensee manufactures, sells, supplies or otherwise disposes of any Product but has not obtained the necessary compliance with laws or approvals as per this Agreement, MPP shall be entitled to immediately terminate this Agreement by providing written notice to the Sublicensee.
DEVELOPMENT AND REGISTRATION. 18 Section 4.03 Marketing...............................................................................21 Section 4.04 Supply of Compound and Product..........................................................26 Section 4.05
DEVELOPMENT AND REGISTRATION. Roche and Agouron acknowledge their mutual intention generally to take a collaborative, commercially reasonable approach to the timely development of the Compound and Products arising out of the Development Program for cancer indications. The parties further acknowledge their mutual willingness to discuss ad hoc agreements to establish appropriate mechanisms for such collaborative development. Recognizing the importance of timely initiation of development activities, however, Roche and Agouron agree to the following basic approach to development of Products for cancer indications and to the conduct of the Global Joint Development Committee activities.
(a) The Global Joint Development Committee shall meet in regular intervals, at least * and shall be co-chaired by representatives from Roche and Agouron. Each party shall be entitled to participate in decisions affecting the Development Program and to attend all key development-related meetings. The meeting locations of the Global Joint Development Committee shall * or at other sites as agreed to by the parties. Meeting minutes shall be promptly prepared and approved by designated representatives of each of the parties. Each party shall pay all of its respective expenses for such meetings.
(b) Each party shall also designate a financial advisor to the Global Joint Development Committee. Each party's members of the Global Joint Development Committee shall reasonably consider the adoption of the other party's development suggestions, and shall accept as many of such development suggestions as are reasonable, based upon medical and business rationale, drug supply, and the need to conduct the development activities in an expeditious manner. If the parties agree, an authorized sublicensee for a Compound which is participating in the development of such Compound may participate in such discussions.
(c) If the Global Joint Development Committee is unable to reach agreement on any decision required of it, the issue shall be submitted for consideration, * If they are unable to agree, then the issue shall be resolved by the *
(d) The decisions of the Global Joint Development Committee shall be binding on the parties and shall be confirmed in writing by designated representatives of each of the parties.
(e) The Global Joint Development Committee shall be responsible for the coordination of the global collaborative development efforts directed to Registration of Products arising out of the Development Program for cancer ...
DEVELOPMENT AND REGISTRATION. 3.1 As of the Effective Date and subject always to ViiV’s retained rights to the 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 Products to be sold or supplied by the Licensee in the Territory under this Agreement.
3.2 Licensee agrees that it will manufacture Raw Materials and Product in a manner consistent with (i) World Health Organization ("WHO") pre-qualification standards; or
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
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.
DEVELOPMENT AND REGISTRATION. 11.1 [Text has been redacted] [Text has been redacted]
11.2 NN shall use commercially reasonable efforts consistent with industry standards for a company of comparable size to NN and shall be solely responsible for developing Product. NN shall conduct, at its expense, any pre-clinical and clinical trials necessary to receive and maintain registrations to sell Product in commercially feasible markets of NN’s choosing.
11.3 [Text has been redacted]
11.4 [Text has been redacted]
11.4.1 [Text has been redacted]
11.4.2 [Text has been redacted]
DEVELOPMENT AND REGISTRATION. 4.01 As of the EFFECTIVE DATE, LICENSEE shall have full control and authority over, and shall be solely responsible for PRODUCTS, including but not limited to the development, registration, manufacture and commercialization of PRODUCTS in the TERRITORY. LICENSEE will exercise its reasonable efforts and diligence in developing and commercializing a PRODUCT in accordance with its business, legal, medical and scientific judgment, and in undertaking investigations and actions required to obtain appropriate governmental approvals to market a PRODUCT in the TERRITORY. All such activity shall be undertaken at LICENSEE's expense.
4.02 LICENSEE shall keep LICENSOR informed in writing, on an annual basis, of the status of the development of PRODUCTS throughout the TERRITORY.
4.03 Except as specified in Appendix E and in Section 4.04, LICENSOR shall have no obligation to provide any support to LICENSEE, whether financially, internal resource or otherwise, for the development and commercialization of PRODUCTS under the terms of this Agreement or otherwise.
4.04 Except to the extent transferred to LICENSEE pursuant to this Agreement, LICENSOR shall maintain its data, records, reports, and other information relating to the research and development of PRODUCTS to the same extent, and with the same level of care, as it would for other pharmaceutical products that it discovers, develops and directly commercializes, provided that such data, records, reports, and other information are in its possession or control as of the EFFECTIVE DATE.
