Background
Manufacturers of pharmaceutical products not only sell products themselves, but also use external partners to get their products to market and to patients. In order to standardise these relationships, a manufacturer should establish standard agreement structures with its distribution partners.
In order to prepare a standard agreement, the manufacturer must consider the relevant local laws and regulations, which may determine, among other things:
- what constitutes the last manufacturing step;
- who holds the marketing authority; and
- who deals with issues such as pharmacovigilance in relation to local authorities.
Within the European Union, such regulations are generally standardised, while in other countries only local parties can hold the marketing authority. Where this is the case, a clear power of attorney should be signed in order to return authority back to the manufacturer.
Below is an example of a table of contents for such a standard agreement. The sections of specific interest to pharmaceutical manufacturers are shown in bold.
MARKETING, SALES, DISTRIBUTION AND LICENSE AGREEMENT
between
XX
and
YY
INDEX
- DEFINITIONS
- DISTRIBUTION RIGHTS
- GENERAL COOPERATION IN DISTRIBUTION.
- REGULATORY MATTERS AND DELIMINATION OF RESPONSIBILITIES
- FORECASTS AND ORDERS
- SUPPLY OF PRODUCTS
- QUALITY AND QUANTITY CONTROL, LIABILITY OF XX
- PRICES OF PRODUCTS
- PAYMENT, TITLE
- STOCK AND STORAGE
- MARKETING OBLIGATIONS
- MINIMUM SALES
- PRODUCT OBSERVATION AND PHARMACOVIGILANCE
- COMPETING PRODUCTS AND INTERESTS IN COMPETING COMPANIES
- GUARANTEES and LIABILITY OF YY, THIRD PARTY CLAIMS, INSURANCE
- INDEPENDENT STATUS
- XX'S INTELLECTUAL PROPERTY RIGHTS
- THIRD PARTIES INTELLECTUAL PROPERTY RIGHTS
- DISCLOSURE OF INFORMATION AND CONFIDENTIALITY
- RECORDS AND BOOKS
- ASSIGNMENT, SUBLICENSES
- TERM AND TERMINATION
- EFFECTS AND PERFORMANCE UPON TERMINATION
- GOVERNING LAW
- JURISDICTION
- MISCELLANEOUS
EXHIBIT
Regulatory Issues and Delimitation of Responsibilities
PREAMBLE
- XX develops and owns analytical, pharmacological, toxicological, medical and clinical documents as well as analyses scientific literature and prepares summaries of product characteristics, labelling/wording for the containers, outer wrappings, package leaflets and expert information for the Products.
- YY is familiar and experienced with the regulatory requirements for the Products in the Territory.
- In order to obtain and maintain Marketing Authorizations and Free-Listing-Positions of the Products and to ensure full compliance with the applicable regulatory requirements in the Territory this EXHIBIT defines responsibilities of each party in regulatory matters and lays down what services each party delivers to the other one and vis-à-vis the Authorities of the Territory.
1. DEFINITIONS
The following terms used in this EXHIBIT shall have the meanings set forth in this Section 1 and shall be limited to them unless the context in which they appear expressly indicates otherwise:
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2. REPRESENTATION
2.1 YY acknowledges XX as the MAH of the Products in the Territory. YY declares that all rights resulting from Marketing Authorizations/Free-Listing-Positions/other rights to place the Products on the market are the sole property of XX.
2.2 YY acts as XX's representative for the Products in the Territory.
2.3 The Parties undertake to collaborate with each other and each Party agrees to provide the other Party with any assistance it may require to ensure compliance with the regulatory requirements of the Products in the Territory. In particular, but not limited, to YY shall provide XX with assistance and/or information, as it might be needed by XX in connection with the drafting of Dossiers, the application, grant, variation, renewal and/or maintenance of Marketing Authorizations/Free-Listing-Positions/other rights to place the Products on the market. Such assistance shall also refer to, but shall not be limited to the preparation of answers to any questions and/or objections from the Authorities of the Territory related to the Products.
2.4 As MAH XX is responsible to conduct all face-to-face negotiations with competent Authorities. YY shall however assist and/or represent XX upon XX's request in connection with such negotiations.
3. YY's RESPONSIBILITIES
3.1 YY has and shall maintain full knowledge of and experience with the applicable Regulatory Requirements relevant for the Products and the Dossiers in the Territory. YY shall provide XX with all information in a timely fashion including on XX'S request accurate translations to English, German or another requested language of Regulatory Requirements and changes thereof. In particular, but not limited to, YY shall monitor and inform XX in good time about applicable time-limits to be met in order to obtain and/or maintain Marketing Authorizations/Free-Listing-Positions/other rights to place the Products on the market and about the current official fees which will be charged for intended applications and/or other measures. YY shall provide XX with – if available – electronic and hard copies of submission forms which are requested by Authorities.
3.2 YY shall take all necessary steps to ensure that correspondence with Authorities including but not limited to applications for Marketing Authorizations/Free-Listing-Positions/other rights to place the Products on the market, answers to questions, objections of Authorities, renewals, variations and PSURs comply with the Regulatory Requirements.
3.3 In relation between the Parties YY shall be responsible for the compliance of the Dossiers and the marketing, sale and distribution of Products with the applicable regulatory requirements in the Territory.
4. MARKETING AUTHORIZATIONS, RENEWALS, VARIATIONS AND FILING OF PSURS
4.1 YY provides XX with information and explanations of the requirements for applications for Marketing Authorizations/Free-Listing-Positions/other rights to place the Products on the market in particular but not limited to the content of the Dossiers, for renewals, for variations and for PSURs of the Products in the Territory.
4.2 Unless otherwise agreed in writing XX shall provide drafts of the required Dossiers in English or German language. Necessary translations into the national language of the Territory will be provided by YY.
4.3 YY shall examine the drafts of the Dossiers provided by XX and suggest changes which are necessary to fulfil the Regulatory Requirements.
4.4 YY shall file the final versions of the documents the applications for Marketing Authorizations, renewals, variations and of PSURs of the Products to the competent Authorities within the given time, in the name and on behalf of XX and in the final version with prior consent of XX.
4.5 YY agrees not to take any action whatsoever which may have a negative impact on the contents, validity or process of granting Marketing Authorizations/Free-Listing-Positions/other rights to place the Products on the market. Without prior consent of XX YY shall refrain from filing applications and/or Dossiers or other documents to the Authorities and from negotiating with the Authorities.
4.6 If YY proposes any changes to labelling/wording for the containers, outer wrappings, package leaflets and/or expert information YY shall provide XX with drafts of the changed texts including on XX's request accurate translations to English, German or another requested language. YY shall not carry out any changes in labelling or wording for the containers, outer wrappings, package leaflets and/or expert information without prior consent/release of XX.
5. FEES
5.1 YY bears all costs in connection with the application, grant, maintenance, variation and/or withdrawal of the Marketing Authorization/Free-Listing-Positions/other rights to place the Products on the market vis-à-vis the Authorities.
5.2 Unless otherwise agreed in writing XX shall reimburse YY the Official Fees within [....] days upon presentation of a reimbursement-invoice accompanied by the original invoices.
6. ORIGINAL DOCUMENTS, COPIES, CONFIRMATIONS
6.1 The Dossiers and other documents provided by XX remain the sole ownership of XX. Upon XX's written request YY shall promptly return by registered mail all Dossiers and other documents requested by XX.
6.2 YY shall confirm receipt of Dossiers and other documents received from XX within [....] business days upon receipt.
6.3 YY shall provide XX with a full set of copies of documents filed to the Authorities. Original documents of the Authorities including but not limited to granted Market Authorisations, renewals, variations, other decisions, notices, question papers, and confirmations of receipt belong to XX. YY shall promptly forward these original documents including on XX's request an accurate translation to English, German or another requested language via registered mail to XX. If and as long as YY is obliged to keep these documents according to Regulatory Requirements in Territory, YY shall forward XX a complete set of copy of all original documents. XX shall confirm receipt of the documents within 4 working days upon receipt.
6.4 YY shall not use XX's Dossiers, other documents or any other information related to the Products for purposes other than for the enforcement of this Agreement. This prohibition shall apply inside and outside the Territory during the term of this Agreement and thereafter. Any breach of this obligation will be considered as a substantial breach of confidentiality obligations according to Section 19.6 of the Marketing, Sales, Distribution and License Agreement.
7. ORGANISATION AND QUALIFIED PERSONS
In order to ensure to carry out its obligations under this Exhibit YY shall appoint and maintain a sufficiently qualified and experienced responsible person for Regulatory Requirements and transmit her/his contact data to XX upon signing of this Exhibit. Any changes of this position shall be communicated in writing to XX without undue delay.
8. CONDITIONS
To the extent of any conflict or inconsistency between this Exhibit and the Marketing, Sales and Distribution Agreement, the terms of this Exhibit shall control in order to ensure regulatory compliance, unless otherwise agreed to in writing between the parties.
IN WITNESS WHEREOF, the PARTIES have caused this EXHIBIT to be executed in two copies by their duly authorised representatives.
EXHIBIT
Pharmacovigilance
PREAMBLE
This EXHIBIT defines the services provided by each Party and the delimitation of responsibilities between the Parties in respect of pharmacovigilance in order to ensure drug safety and to meet the regulatory requirements imposed by the applicable laws.
1. DEFINITIONS
The following terms used in this EXHIBIT shall have the meanings set forth in this Section 1 and shall be limited to them unless the context in which they appear expressly indicates otherwise.
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2. OBJECTIVES
The parties shall ensure that all global and local pharmacovigilance obligations are fulfilled, pharmacovigilance representatives are nominated, all pharmacovigilance personnel have the required qualifications and a working pharmacovigilance system is established within both parties.
3. REPRESENTATION BY YY
3.1 In line with Pharmacovigilance Requirements YY shall have permanently and continuously at his disposal an appropriately qualified and reliable Local QPPV who is responsible for fulfilment of Pharmacovigilance Requirements in the Territory and, in case of his absence, a Repr. Local QPPV.
3.2 If the notification of a qualified person responsible for pharmacovigilance issues for the Territory to the Authorities is requested by national law, YY shall notify in the name of XX the Local QPPV to the Authorities and maintain this position.
3.3 YY acknowledges that XX as MAH is responsible for pharmacovigilance vis-à-vis the Authorities and has appointed an appropriately qualified and reliable Global QPPV and Repr. of Global QPPV. Local QPPV, respectively Repr. Local QPPV will follow and carry out the instructions given by Global QPPV and/or Repr. Global QPPV.
3.4 YY is willing to accept, implement and follow Standard Operating Procedures (SOPs), processes, forms and updates thereof provided by XX with a view to ensure and facilitate fulfilment of global and local pharmacovigilance requirements.
4. YY's GENERAL RESPONSIBILITIES
4.1 YY has and shall maintain full knowledge and experience with the applicable Pharmacovigilance Requirements relevant for the Products in the Territory. YY shall provide XX with all information required to fulfil Pharmacovigilance Requirements in a timely fashion. In particular, but not limited to, YY shall provide XX with copies of Pharmacovigilance Requirements and changes thereof including on XX's request accurate translations into the English language. YY shall provide XX with – if available – electronic and hard copies of ADR Report and other submission forms which are requested by Authorities.
4.2 YY is responsible for the submission of ADR reports to the Authorities. YY shall monitor applicable time-limits and inform XX in good time on measures required by Pharmacovigilance Requirements in order to meet applicable time-limits.
4.3 In case of a necessary recall, YY shall implement the measures required in the Territory by the applicable laws and other legal provisions of the Territory in accordance with XX.
4.4 In relation between the Parties, YY shall be responsible for the compliance of the marketing, sale and distribution of the Products with the applicable Pharmacovigilance Requirements in the Territory.
5. XX's GENERAL DUTIES
5.1 As MAH, XX maintains and coordinates the global pharmacovigilance system and supports YY with any information required.
5.2 XX is responsible for the review, medical evaluation and analysis of ADRs. It identifies ADRs and provides assessments of seriousness, expectedness and causality for ADRs.
5.3 XX is responsible for screening the relevant scientific literature for ADR and for maintaining a complete safety database.
5.4 XX shall be entitled to audit YY's Pharmacovigilance system upon reasonable notice and during normal business hours to ensure that the provisions of this Agreement and the Pharmacovigilance Requirements are complied with by YY.
5.5 XX is prepared to provide training of the Local QPPV and Repr. Local QPPV.
6. YY's COLLECTION OF ADR
6.1 YY is responsible for collecting ADR associated with the use of the Products in the Territory derived from all sources, including but not limited to reports from health care professionals, consumers, attorneys, sales representatives, third parties and Authorities. YY is also responsible for collecting literature reports concerning the Products and ingredients published in scientific literature in the Territory. YY also collects reports about interactions, overdose, abuse/misuse, exposure during pregnancy, effects of long-term treatment even if not resulting in ADRs.
6.2 The date of initial receipt of ADR must be accurately documented on each report. YY must not change or destruct an ADR provided in written form. YY shall immediately record in written form orally provided ADR as reported and without own evaluations or interpretations in an accurate memo.
6.3 YY shall forward to XX copies of each ADR provided in written form and of each memo of orally reported ADR [including translations thereof to English or any other relevant language].
7. HANDLING OF ADR REPORTS AND OF AUTHORITIES' REQUESTS
7.1 YY shall forward all ADR (SADR and non serious ADR) to XX within two (2) calendar days after the initial receipt date. Requests from Authorities concerning pharmacovigilance-relevant information shall be forwarded immediately, and in case of urgency by phone, no later than within [.....] hours after initial receipt.
7.2 XX provides YY with a written assessment of reported SADR and draft of the required SADR report within [.....] calendar days. The same applies if XX identifies a SADR outside the Territory being also relevant for one of the Products in the Territory. Information about assessment of non serious ADR are transmitted to YY in due time. Drafts of answers on requests of Authorities shall be forwarded to YY immediately and in case of urgency no later than within [.....] hours after receipt.
7.3 YY shall examine the drafts provided by XX, propose any necessary changes and agree on the final version with XX. YY shall submit the final versions agreed upon to the Authorities within the given time in the name of XX. Non-serious ADR must be reported within PSURs following the procedure laid down in EXHIBIT Regulatory Issues and Delimitation of Responsibilities .
7.4 The language of all pharmacovigilance data exchange between the Parties will be English. If submissions to Authorities are required in the language of the Territory the YY is responsible for accurate translation.
8. RECORDS
Both Parties maintain reports and all related documentation for a time period required by applicable laws and other legal provisions in the territories they are responsible for.
9. ORGANISATION AND CONTACT PERSONS
9.1 The Parties designate the qualified persons named in the ANNEX 1 to this EXHIBIT. Global QPPV or Repr. Global QPPV are approachable 24 hours a day. YY ensures that Local QPPV and Repr. Local QPPV are approachable as required by Regulatory Requirements.
9.2 All data must be transmitted to these Responsible Persons, using the phone numbers, e-mail addresses and/or fax numbers listed in the ANNEX 1 to this EXHIBIT. In case of urgency transfer of data must be announced by phone.
9.3 Any changes in contact persons and/or contact data shall be immediately communicated to the other party.
10. CHANGES IN LEGAL REQUIREMENTS
XX and YY agree to update this Agreement according to any changes made in pharmacovigilance and/or other legal requirements.
11. CONDITIONS
To the extent of any conflict or inconsistency between this EXHIBIT and the Marketing, Sales and Distribution Agreement, the terms of this EXHIBIT shall prevail in order to ensure pharmacovigilance compliance, unless otherwise agreed to in writing between the parties.
ANNEX 1 to EXHIBIT
Responsible Contact Persons for Pharmacovigilance
Availability of XX's responsible persons
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Availability of YY's responsible persons
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For further information on this topic please contact Tatjana Schroeder at SKW Schwarz Rechtsanwälte by telephone (+49 69 630 001 0) or email ([email protected]). The SKW Schwarz Rechtsanwälte website can be accessed at www.skwschwarz.de .
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