Obligations of OCD. In addition to the other obligations of OCD otherwise specified in the Agreement, OCD shall, at its sole expense, have the following obligations, exercisable by itself or its Affiliates, Sub-Licensees or Sub-Distributors (subject to Sections 4.2.13 and 18.1.2) during the Term: 4.2.1 OCD shall use All Reasonable Endeavours to carry out its obligations under the Development Plan to seek and obtain Regulatory Approval of the Products in Territory B, at OCD’s sole expense. 4.2.2 OCD shall use All Reasonable Endeavours to Commercialize the Products for the Hospital Market in the Territory and the Donor Testing Market in Territory B. 4.2.3 OCD shall use the Dossiers, Know-how and the Other Confidential Information supplied to it by Quotient solely and exclusively for the Commercialization of the Products in the Territory, as applicable. 4.2.4 Except as provided in Section 6, OCD shall not manufacture, or procure the manufacture from a Third Party of, the Products, but obtain supply of commercial Products exclusively from Quotient or from suppliers designated by Quotient in accordance with this Agreement. 4.2.5 OCD shall use All Reasonable Endeavours to complete all formalities and activities necessary to obtain all Regulatory Approvals for the Products in Territory B in accordance with the timetable for particular countries in Territory B set forth in the Development Plan, subject to Sections 3.2.4 and 14.4. In countries in which it can do so under applicable laws, OCD shall hold all Regulatory Approvals for the Products in Territory B in its own name. In all other countries in Territory B, the Regulatory Approval shall be held by Suisse SA. In cases where OCD holds the Regulatory Approval, OCD shall be responsible for complying with all the obligations of the holder of such Regulatory Approvals. 4.2.6 OCD shall provide information relating to the progress of any Regulatory Approval in Territory B by submitting to Quotient all documents and/or communications addressed to Regulatory Authorities or other governmental authorities which relate to Regulatory Approval of the Products. OCD shall inform Quotient in advance of all key meetings or key conference calls with the regulatory authorities in Territory B. OCD shall have the right to require Quotient to participate in the same if reasonably necessary. In relation to filings for Regulatory Approval, and in circumstances in which OCD holds the Regulatory Approval, OCD shall notify Quotient in writing of any changes to the Products that are required by Regulatory Authorities or other governmental authorities having jurisdiction in Territory B. [***] CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION 27 4.2.7 OCD shall retain and archive all documentation relating to Regulatory Approvals filed or held by it in Territory B. 4.2.8 Once Suisse SA is the Regulatory Approval holder in any country in Territory B, Suisse SA hereby grants to OCD irrevocable permission to cross refer to any Regulatory Approval when OCD is conducting Development or Commercialization of Product in Territory B and to the extent required for legal or regulatory purposes, OCD will, within thirty (30) days of such request, supply Quotient with a copy of the Regulatory Approval, if not previously provided. 4.2.9 Within six (6) months of the Effective Date and on each anniversary of the Effective Date thereafter, prepare in the English language a Commercialization Plan for the following calendar year which it shall submit to the Steering Group for the purpose of coordinating Commercialization of Products in the Territory. OCD must use All Reasonable Endeavours to start Commercializing the Products within [***] after the Approval Date in such country, provided that Quotient performs its obligations to supply Product as provided in this Agreement as necessary to enable such Commercialization in such country. Each draft Commercialization Plan shall be drafted to be consistent with Section 4.2.1. The Steering Group shall have thirty (30) days to review and comment on each Commercialization Plan. OCD shall reasonably consider such comments. 4.2.10 During the term OCD shall: (a) comply with any reasonable and appropriate policies established by the Steering Group from time to time relating to the promotional positioning of the Products in the Hospital Market in the Territory or the Donor Testing Market in Territory B; (b) only sell the Instruments and Consumables separately from products that are not Products and not in any kind of bundle with such other products; (c) furnish Quotient with calendar quarterly sales reports for Products; (d) identify and communicate in writing to Quotient any additions or alterations in the labels, package inserts, trade names or markings on or for Products required by OCD or the applicable laws and regulations in the Territory, with the Parties agreeing in advance in writing on their implementation; (e) maintain adequate insurance in respect of OCD’s stocks of the Products against loss or damage by theft, fire, ▇▇▇▇▇, ▇▇▇▇▇▇▇, riot; and [***] CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION 28 (f) provide the First Level Support and Second Level Support for the Instruments, in accordance with Section 11. 4.2.11 OCD shall comply with all laws and regulations applicable in the Territory dealing with the sale and distribution, including the Commercialization, of the Products purchased under this Agreement, including applicable laws relating to data protection and safety in the workplace, and laws and regulations prohibiting the giving of anything of value, directly or indirectly, to influence improperly the supply or sale of the Products in the Territory. Without limiting the generality of the foregoing, OCD shall, at its sole expense, obtain and maintain all applicable licenses and governmental approvals that may be necessary to permit the importation of the Products and the Commercialization of the Products by OCD, other than those Regulatory Approvals for which Quotient is responsible pursuant to Section 4.1. 4.2.12 OCD shall not do anything that would cause either Party to be in violation of the US Foreign Corrupt Practices Act, the UK ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇, or any other anti-bribery laws applicable to either Party’s performing under this Agreement.
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Sources: Distribution and Supply Agreement
Obligations of OCD. In addition to the other obligations of OCD otherwise specified in the Agreement, OCD shall, at its sole expense, have the following obligations, exercisable by itself or its Affiliates, Sub-Licensees or Sub-Distributors (subject to Sections 4.2.13 and 18.1.2) during the Term:
4.2.1 OCD shall use All Reasonable Endeavours to carry out its obligations under the Development Plan to seek and obtain Regulatory Approval of the Products in Territory B, at OCD’s sole expense.
4.2.2 OCD shall use All Reasonable Endeavours to Commercialize the Products for the Hospital Market in the Territory and the Donor Testing Market in Territory B.
4.2.3 OCD shall use the Dossiers, Know-how and the Other Confidential Information supplied to it by Quotient solely and exclusively for the Commercialization of the Products in the Territory, as applicable.
4.2.4 Except as provided in Section 6, OCD shall not manufacture, or procure the manufacture from a Third Party of, the Products, but obtain supply of commercial Products exclusively from Quotient or from suppliers designated by Quotient in accordance with this Agreement.
4.2.5 OCD shall use All Reasonable Endeavours to complete all formalities and activities necessary to obtain all Regulatory Approvals for the Products in Territory B in accordance with the timetable for particular countries in Territory B set forth in the Development Plan, subject to Sections 3.2.4 and 14.4. In countries in which it can do so under applicable laws, OCD shall hold all Regulatory Approvals for the Products in Territory B in its own name. In all other countries in Territory B, the Regulatory Approval shall be held by Suisse SA. In cases where OCD holds the Regulatory Approval, OCD shall be responsible for complying with all the obligations of the holder of such Regulatory Approvals.
4.2.6 OCD shall provide information relating to the progress of any Regulatory Approval in Territory B by submitting to Quotient all documents and/or communications addressed to Regulatory Authorities or other governmental authorities which relate to Regulatory Approval of the Products. OCD shall inform Quotient in advance of all key meetings or key conference calls with the regulatory authorities in Territory B. OCD shall have the right to require Quotient to participate in the same if reasonably necessary. In relation to filings for Regulatory Approval, and in circumstances in which OCD holds the Regulatory Approval, OCD shall notify Quotient in writing of any changes to the Products that are required by Regulatory Authorities or other governmental authorities having jurisdiction in Territory B. [***] CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION 27B.
4.2.7 OCD shall retain and archive all documentation relating to Regulatory Approvals filed or held by it in Territory B.
4.2.8 Once Suisse SA is the Regulatory Approval holder in any country in Territory B, Suisse SA hereby grants to OCD irrevocable permission to cross refer to any Regulatory Approval when OCD is conducting Development or Commercialization of Product in Territory B and to the extent required for legal or regulatory purposes, OCD will, within thirty (30) days of such request, supply Quotient with a copy of the Regulatory Approval, if not previously provided.
4.2.9 Within six (6) months of the Effective Date and on each anniversary of the Effective Date thereafter, prepare in the English language a Commercialization Plan for the following calendar year which it shall submit to the Steering Group for the purpose of coordinating Commercialization of Products in the Territory. OCD must use All Reasonable Endeavours to start Commercializing the Products within [***] after the Approval Date in such country, provided that Quotient performs its obligations to supply Product as provided in this Agreement as necessary to enable such Commercialization in such country. Each draft Commercialization Plan shall be drafted to be consistent with Section 4.2.1. The Steering Group shall have thirty (30) days to review and comment on each Commercialization Plan. OCD shall reasonably consider such comments.
4.2.10 During the term OCD shall:
(a) comply with any reasonable and appropriate policies established by the Steering Group from time to time relating to the promotional positioning of the Products in the Hospital Market in the Territory or the Donor Testing Market in Territory B;
(b) only sell the Instruments and Consumables separately from products that are not Products and not in any kind of bundle with such other products;
(c) furnish Quotient with calendar quarterly sales reports for Products;
(d) identify and communicate in writing to Quotient any additions or alterations in the labels, package inserts, trade names or markings on or for Products required by OCD or the applicable laws and regulations in the Territory, with the Parties agreeing in advance in writing on their implementation;
(e) maintain adequate insurance in respect of OCD’s stocks of the Products against loss or damage by theft, fire, ▇▇▇▇▇, ▇▇▇▇▇▇▇, riot; and [***] CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION 28and
(f) provide the First Level Support and Second Level Support for the Instruments, in accordance with Section 11.
4.2.11 OCD shall comply with all laws and regulations applicable in the Territory dealing with the sale and distribution, including the Commercialization, of the Products purchased under this Agreement, including applicable laws relating to data protection and safety in the workplace, and laws and regulations prohibiting the giving of anything of value, directly or indirectly, to influence improperly the supply or sale of the Products in the Territory. Without limiting the generality of the foregoing, OCD shall, at its sole expense, obtain and maintain all applicable licenses and governmental approvals that may be necessary to permit the importation of the Products and the Commercialization of the Products by OCD, other than those Regulatory Approvals for which Quotient is responsible pursuant to Section 4.1.
4.2.12 OCD shall not do anything that would cause either Party to be in violation of the US Foreign Corrupt Practices Act, the UK ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇, or any other anti-bribery laws applicable to either Party’s performing under this Agreement.
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