General Terms and Conditions of Purchase

IDT Biologika GmbH

You can find the General Terms and Conditions of Purchase of IDT Biologika GmbH here.

TEW Technik-Energie-Wasser-Servicegesellschaft mbH

You can find the General Terms and Conditions of Purchase of TEW Technik-Energie-Wasser-Servicegesellschaft mbH here.


 
 

Data privacy policy

1. An overview of data protection

General

The following gives a simple overview of what happens to your personal information when you visit our website. Personal information is any data with which you could be personally identified. Detailed information on the subject of data protection can be found in our privacy policy found below.

Data collection on our website

Who is responsible for the data collection on this website?

The data collected on this website are processed by the website operator. The operator's contact details can be found in the website's required legal notice.

How do we collect your data?

Some data are collected when you provide it to us. This could, for example, be data you enter on a contact form.
Other data are collected automatically by our IT systems when you visit the website. These data are primarily technical data such as the browser and operating system you are using or when you accessed the page. These data are collected automatically as soon as you enter our website.

What do we use your data for?

Part of the data is collected to ensure the proper functioning of the website. Other data can be used to analyze how visitors use the site.

What rights do you have regarding your data?

You always have the right to request information about your stored data, its origin, its recipients, and the purpose of its collection at no charge. You also have the right to request that it be corrected, blocked, or deleted. You can contact us at any time using the address given in the legal notice if you have further questions about the issue of privacy and data protection. You may also, of course, file a complaint with the competent regulatory authorities.

Analytics and third-party tools

When visiting our website, statistical analyses may be made of your surfing behavior. This happens primarily using cookies and analytics. The analysis of your surfing behavior is usually anonymous, i.e. we will not be able to identify you from this data. You can object to this analysis or prevent it by not using certain tools. Detailed information can be found in the following privacy policy.
You can object to this analysis. We will inform you below about how to exercise your options in this regard.

2. General information and mandatory information

Data protection

The operators of this website take the protection of your personal data very seriously. We treat your personal data as confidential and in accordance with the statutory data protection regulations and this privacy policy.
If you use this website, various pieces of personal data will be collected. Personal information is any data with which you could be personally identified. This privacy policy explains what information we collect and what we use it for. It also explains how and for what purpose this happens.
Please note that data transmitted via the internet (e.g. via email communication) may be subject to security breaches. Complete protection of your data from third-party access is not possible.

Notice concerning the party responsible for this website

The party responsible for processing data on this website is:
IDT Biologika GmbH
Am Pharmapark
06861 Dessau-Roßlau
Telephone: +49 (0) 34901 8850
Email: info@idt-biologika.com
The responsible party is the natural or legal person who alone or jointly with others decides on the purposes and means of processing personal data (names, email addresses, etc.).

Revocation of your consent to the processing of your data

Many data processing operations are only possible with your express consent. You may revoke your consent at any time with future effect. An informal email making this request is sufficient. The data processed before we receive your request may still be legally processed.

SSL or TLS encryption

This site uses SSL or TLS encryption for security reasons and for the protection of the transmission of confidential content, such as the inquiries you send to us as the site operator. You can recognize an encrypted connection in your browser's address line when it changes from "http://" to "https://" and the lock icon is displayed in your browser's address bar.
If SSL or TLS encryption is activated, the data you transfer to us cannot be read by third parties.

Information, blocking, deletion

As permitted by law, you have the right to be provided at any time with information free of charge about any of your personal data that is stored as well as its origin, the recipient and the purpose for which it has been processed. You also have the right to have this data corrected, blocked or deleted. You can contact us at any time using the address given in our legal notice if you have further questions on the topic of personal data.

3. Data protection officer

Statutory data protection officer

We have appointed a data protection officer for our company.
IDT Biologika GmbH
Datenschutzbeauftragter
Am Pharmapark
06861 Dessau-Roßlau
Mail: datenschutz@idt-biologika.de

4. Data collection on our website

Cookies

Some of our web pages use cookies. Cookies do not harm your computer and do not contain any viruses. Cookies help make our website more user-friendly, efficient, and secure. Cookies are small text files that are stored on your computer and saved by your browser.
Most of the cookies we use are so-called "session cookies." They are automatically deleted after your visit. Other cookies remain in your device's memory until you delete them. These cookies make it possible to recognize your browser when you next visit the site.
You can configure your browser to inform you about the use of cookies so that you can decide on a case-by-case basis whether to accept or reject a cookie. Alternatively, your browser can be configured to automatically accept cookies under certain conditions or to always reject them, or to automatically delete cookies when closing your browser. Disabling cookies may limit the functionality of this website.
Cookies which are necessary to allow electronic communications or to provide certain functions you wish to use (such as the shopping cart) are stored pursuant to Art. 6 paragraph 1, letter f of DSGVO. The website operator has a legitimate interest in the storage of cookies to ensure an optimized service provided free of technical errors. If other cookies (such as those used to analyze your surfing behavior) are also stored, they will be treated separately in this privacy policy.

Server log files

The website provider automatically collects and stores information that your browser automatically transmits to us in "server log files". The server log files are deleted after 7 days (according to Federal Supreme Court decision July 13, 2014 - III ZR 391/13). These are:

  • Browser type and browser version
  • Operating system used
  • Referrer URL
  • Host name of the accessing computer
  • Time of the server request
  • IP address

These data will not be combined with data from other sources.
The basis for data processing is Art. 6 (1) (f) DSGVO, which allows the processing of data to fulfill a contract or for measures preliminary to a contract.

Contact form

Should you send us questions via the contact form, we will collect the data entered on the form, including the contact details you provide, to answer your question and any follow-up questions. We do not share this information without your permission.
We will, therefore, process any data you enter onto the contact form only with your consent per Art. 6 (1)(a) DSGVO. You may revoke your consent at any time. An informal email making this request is sufficient. The data processed before we receive your request may still be legally processed.
We will retain the data you provide on the contact form until you request its deletion, revoke your consent for its storage, or the purpose for its storage no longer pertains (e.g. after fulfilling your request). Any mandatory statutory provisions, especially those regarding mandatory data retention periods, remain unaffected by this provision.

5. Social media

Twitter plugin

Functions of the Twitter service have been integrated into our website and app. These features are offered by Twitter Inc., 1355 Market Street, Suite 900, San Francisco, CA 94103, USA. When you use Twitter and the “Retweet” function, the websites you visit are connected to your Twitter account and made known to other users. In doing so, data will also be transferred to Twitter. We would like to point out that, as the provider of these pages, we have no knowledge of the content of the data transmitted or how it will be used by Twitter. For more information on Twitter's privacy policy, please go to https://twitter.com/privacy.
Your privacy preferences with Twitter can be modified in your account settings at https://twitter.com/account/settings.

6. Analytics and advertising

Google Analytics

This website uses Google Analytics, a web analytics service. It is operated by Google Inc., 1600 Amphitheatre Parkway, Mountain View, CA 94043, USA.
Google Analytics uses so-called "cookies". These are text files that are stored on your computer and that allow an analysis of the use of the website by you. The information generated by the cookie about your use of this website is usually transmitted to a Google server in the USA and stored there.
Google Analytics cookies are stored based on Art. 6 (1) (f) DSGVO. The website operator has a legitimate interest in analyzing user behavior to optimize both its website and its advertising.

IP anonymization

We have activated the IP anonymization feature on this website. Your IP address will be shortened by Google within the European Union or other parties to the Agreement on the European Economic Area prior to transmission to the United States. Only in exceptional cases is the full IP address sent to a Google server in the US and shortened there. Google will use this information on behalf of the operator of this website to evaluate your use of the website, to compile reports on website activity, and to provide other services regarding website activity and Internet usage for the website operator. The IP address transmitted by your browser as part of Google Analytics will not be merged with any other data held by Google.

Browser plugin

You can prevent these cookies being stored by selecting the appropriate settings in your browser. However, we wish to point out that doing so may mean you will not be able to enjoy the full functionality of this website. You can also prevent the data generated by cookies about your use of the website (incl. your IP address) from being passed to Google, and the processing of these data by Google, by downloading and installing the browser plugin available at the following link:https://tools.google.com/dlpage/gaoptout?hl=en.

Objecting to the collection of data

You can prevent the collection of your data by Google Analytics by clicking on the following link. An opt-out cookie will be set to prevent your data from being collected on future visits to this site: Disable Google Analytics.
For more information about how Google Analytics handles user data, see Google's privacy policy: https://support.google.com/analytics/answer/6004245?hl=en.

Outsourced data processing

We have entered into an agreement with Google for the outsourcing of our data processing and fully implement the strict requirements of the German data protection authorities when using Google Analytics.

7. Plugins and tools

YouTube

Our website uses plugins from YouTube, which is operated by Google. The operator of the pages is YouTube LLC, 901 Cherry Ave., San Bruno, CA 94066, USA.
If you visit one of our pages featuring a YouTube plugin, a connection to the YouTube servers is established. Here the YouTube server is informed about which of our pages you have visited.
If you're logged in to your YouTube account, YouTube allows you to associate your browsing behavior directly with your personal profile. You can prevent this by logging out of your YouTube account.
YouTube is used to help make our website appealing. This constitutes a justified interest pursuant to Art. 6 (1) (f) DSGVO.
Further information about handling user data, can be found in the data protection declaration of YouTube under https://www.google.de/intl/de/policies/privacy.

Vimeo

Our website uses features provided by the Vimeo video portal. This service is provided by Vimeo Inc., 555 West 18th Street, New York, New York 10011, USA.
If you visit one of our pages featuring a Vimeo plugin, a connection to the Vimeo servers is established. Here the Vimeo server is informed about which of our pages you have visited. In addition, Vimeo will receive your IP address. This also applies if you are not logged in to Vimeo when you visit our website or do not have a Vimeo account. The information is transmitted to a Vimeo server in the US, where it is stored.
If you are logged in to your Vimeo account, Vimeo allows you to associate your browsing behavior directly with your personal profile. You can prevent this by logging out of your Vimeo account.
For more information on how to handle user data, please refer to the Vimeo Privacy Policy at https://vimeo.com/privacy.

Google Maps

This site uses the Google Maps map service via an API. It is operated by Google Inc., 1600 Amphitheatre Parkway, Mountain View, CA 94043, USA.
To use Google Maps, it is necessary to save your IP address. This information is generally transmitted to a Google server in the USA and stored there. The provider of this site has no influence on this data transfer.
The use of Google Maps is in the interest of making our website appealing and to facilitate the location of places specified by us on the website. This constitutes a justified interest pursuant to Art. 6 (1) (f) DSGVO.
Further information about handling user data, can be found in the data protection declaration of Google at https://www.google.de/intl/de/policies/privacy/.

8. Data processing in the context of Pharmacovigilance

Thank you for any report of an adverse event related to a veterinary medicinal product of IDT. These data are used and shared solely for pharmacovigilance purposes.
We are officially obligated to collect information regarding adverse events following the use of IDT products or other problems related to veterinary medicinal products of IDT, to evaluate them, to report them to competent authorities, and to archive the related documents for a statutory period. This obligation applies worldwide in all distribution countries, i. e. also in countries outside the scope of GDPR.
In this context, personal data are also collected. However, these data are used only for specific purposes and to the extent necessary to fulfill applicable legal requirements.
As part of the report to the competent authorities, information of the event is communicated in detail and provided, however, the transfer of personal data takes place only in anonymous form. Specifically, only the function (e.g. veterinarian, pet owner, etc.), the country of origin, the first letter of the surname, and the first digit of the postal code of the contact persons are transmitted. Concerning human exposure in connection with a veterinary medicinal product of IDT, the age and sex as well as the first letter of the first and last name of the person concerned are reported.
Even when information about the reported event is required to be forwarded to to subsidiaries, business partners or contractors of IDT, personal data will not be fully disclosed or IDT will protect the data in accordance with this data privacy statement, respectively.
Personal data will be stored by IDT after the date it has been gathered as long as necessary to comply with the applicable legal retention periods set forth for the respective circumstances which required the data collection. This retention period is currently until at least one year after the product expiry date, but not less than five years (§ 20 Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV), the regulation governing the manufacture and distribution of pharmaceuticals and agents).
Data processing in the context of pharmacovigilance serves the fulfillment of legal obligations pursuant to (Article 6 (1) (c) GDPR); outside the EU pursuant to Article 6, Paragraph 1 lit. f and Art. 49 para. 1 lit. e.
On request, information can be obtained regarding the actual whereabouts and use of your data. With regard to the disclosure, blocking and deletion of such data, the provisions referenced in Par. VI) of this data protection policy apply.
Anyone who disagrees with the processing and archiving of its personal data should please contact the responsible data protection department of IDT set forth in Par. II. above.

 

Financial Conflict of Interest policy

I. Introduction and Objective

When IDT Biologika GmbH (“IDT”) is involved with research funded by the Public Health Service of the U.S. Department of Health and Human Services (“PHS”), and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (“NIH”), IDT must, and shall, comply with the requirements of 45 C.F.R. Part 94, “Responsible Prospective Contractors,” which promote objectivity in research and establish standards to provide a reasonable expectation that the design, conduct, and reporting of research performed under PHS contracts will be free from bias related to financial conflicts of interest.
The purpose of this Financial Conflict of Interest Policy (this “Policy”) is to establish the standards for compliance with 45 C.F.R. Part 94 and for determining the existence of conflicts of interest, the requirements for disclosing conflicts, and the process for reducing, managing, or eliminating conflicts.


II. Application

This Policy applies to all proposed and on-going PHS-funded research and any other research that IDT designates as subject to this Policy. Such PHS-funded research includes research authorized under the PHS Act (42 U.S.C. 201 et seq.) or other statutory authority, such as a research grant, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, conference and workshop grant, or research resources award.


III. Policy

A. Definitions.

Capitalized terms not otherwise defined herein shall have the meanings ascribed to such terms in 45 C.F.R. Part 94.

1. Contractor

means an entity that provides property or services under contract for the direct benefit or use of the U.S. Federal Government.

2. Financial conflict of interest (“FCOI”)

means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

3. FCOI report

means a report of a financial conflict of interest to a PHS awarding component.

4. Financial interest

means anything of monetary value, whether or not the value is readily ascertainable.

5. Institutional Responsibilities

means an Investigator’s professional responsibilities on behalf of IDT, which may include: research, research consultation, teaching, professional practice, and institutional committee memberships.

6. Investigator

means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

7. Key personnel

includes a project director or principal Investigator of a PHS-funded research project and any other personnel considered to be essential to work performance and identified as key personnel in the contract proposal and contract.

8. PHS Awarding Component

means the organizational unit of PHS that funds research subject to 45 C.F.R. Part 94.

9. Significant Financial Interest

means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s Institutional Responsibilities:

a) With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity (salary and any payment for services not otherwise identified as salary such as consulting fees, honoraria, or paid authorship) in the twelve (12) months preceding the disclosure aggregated with the value of any equity in the entity (for example, stock, stock options, or other ownership interests as determined through reference to public prices or other reasonable measures of fair market value) exceeds $5,000.

b) With regard to any non-publicly traded entity, a Significant Financial Interest exists if the aggregated value of any remuneration received from the entity in the twelve (12) months preceding the disclosure exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest.

c) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

The term Significant Financial Interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by IDT to the Investigator if the Investigator is currently employed or otherwise appointed by IDT, including intellectual property rights assigned to IDT and agreements to share in royalties related to such rights; any ownership interest in IDT held by the Investigator; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

B. General Principles

1. IDT will fully comply with the federal rule at 45 C.F.R. Part 94 titled “Responsible Prospective Contractors,” as it relates to all Research, grants or awards for which funding from PHS or any PHS Awarding Component is sought or received (“PHS-funded research”).
2. The requirements of this Policy and the management of the processes necessary to implement this Policy are set forth in the following Procedures.

IV. Procedures

A. Investigator Disclosures

1. Project-Specific Disclosures.

IDT requires that each Investigator who is planning to participate in the PHS-funded research disclose to Thomas Picek the Investigator’s Significant Financial Interests related to the Investigator’s Institutional Responsibilities (and those of the Investigator’s spouse and dependent children) no later than the time of application for PHS-funded research.

2. Annual Disclosures.

IDT requires that each Investigator who is participating in the PHS-funded research submit an updated Disclosure of Significant Financial Interests form at least annually during the period of the award. Such disclosure shall include any information that was not disclosed initially to IDT or in a subsequent disclosure of Significant Financial Interests (e.g., any FCOI identified on a PHS-funded research project that was transferred from another institution), and shall include updated information regarding any previously disclosed Significant Financial Interest (e.g., the updated value of a previously disclosed equity interest).

3. Investigator Travel.

Investigators also must disclose the occurrence of any reimbursed or sponsored travel related to their Institutional Responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. This disclosure must include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.

4. Disclosure Updates.

IDT requires that Investigators update IDT within thirty (30) days in the event that they discover or acquire a new Significant Financial Interest.

B. Review of Disclosures and Determination of FCOI

1. Review of Disclosures.

IDT is responsible for reviewing any disclosures of (i) Investigator Travel and/or (ii) a Significant Financial Interest belonging to an Investigator, and Investigator’s spouse, or the Investigator’s dependent children, to the extent either reasonably appear to relate to the Investigator’s Institutional Responsibilities (collectively, (i) and (ii) are included in the definition of “Significant Financial Interests”). IDT may, in its discretion, identify through procedures or other guidance documents, additional interests that it will review.

2. Relatedness Determination.

IDT will evaluate each disclosure to determine whether it relates to the Investigator’s Research or Institutional Responsibilities. A Significant Financial Interest will be found to relate to the Investigator’s Research or Institutional Responsibilities when it is reasonably determined that the Significant Financial Interest could be affected by the research, or is in an entity whose financial interest could be affected by the Research or Institutional Responsibilities. The Investigator may be asked to provide information to assist in the assessment of whether a Significant Financial Interest is related to the Investigator’s research or Institutional Responsibilities.

3. Timing of Review.

a) Initial Significant Financial Interests.
For PHS-funded research, Significant Financial Interests disclosed at the time of the funding and/or protocol application will be evaluated prior to the expenditure of any funds. For all other research subject to this Policy, Significant Financial Interests disclosed at the time of the funding and/or protocol application will be evaluated prior to the initiation of the research activities.
b) Updated Significant Financial Interests.
To the extent a new Significant Financial Interest is disclosed to IDT in the course of an ongoing research project, IDT will, within sixty (60) days from the date of the disclosure: (i) determine if the Significant Financial Interest relates to the Investigator’s research; (ii) if it relates, determine if it qualifies as an FCOI; and (iii) if it is an FCOI, implement on at least an interim basis a management plan as described below. IDT may, depending on the circumstances, conclude that additional interim measures are necessary with regard to the Investigator’s participation in the research between the date of disclosure and the completion of IDT’s review.

4. Determination of FCOI.

An FCOI will be found to exist when a Significant Financial Interest related to the Investigator’s research could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. IDT will maintain a process and written criteria for making FCOI determinations, and will evaluate and revise such guidelines as appropriate.

C. Management of FCOI

1. Management of FCOI.

For any identified FCOI, IDT shall take appropriate action to manage the conflict in order to reduce the potential for it to compromise the safety or validity of the research. Research in which an Investigator is found to have an FCOI will not be permitted to proceed until the Investigator has agreed to implement an acceptable management plan. The appropriate techniques identified by IDT to manage an identified FCOI will be outlined in a written management plan. Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to:

a) Public disclosure of the FCOI (e.g., when presenting or publishing the research).
b) For research involving human subjects, disclosure of the FCOI directly to participants.
c) Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI.
d) Modification of the research plan.
e) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research.
f) Reduction or elimination of the financial interest (e.g., sale of an equity interest).
g) Severance of relationships that create FCOI.

2. Disclosure for PHS-Funded Drug/Device Research.

In any case in which the U.S. Department of Health and Human Services determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by IDT, the Investigator will be required to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.

D. Retrospective Reviews; Mitigation Reports

1. Identification of Significant Financial Interests Not Timely Disclosed or Reviewed.

In the event IDT identifies a Significant Financial Interest that was not disclosed in a timely manner by an Investigator or, for whatever reason, was not previously reviewed by IDT in accordance with this Policy during an on-going research project (e.g., was not timely reviewed or reported by a subrecipient), IDT will, within sixty (60) days of identifying such a Significant Financial Interest: (i) determine if the Significant Financial relates to the Investigator’s research; (ii) if it relates, determine if it qualifies as an FCOI; and (iii) if it is an FCOI, implement on at least an interim basis a management plan in accordance this Policy to manage the FCOI going forward. Depending on the nature of the FCOI, if a retrospective review for bias is required, IDT may determine that additional interim measures are necessary with regard to the Investigator’s participation in the research between the date that the FCOI is determined and the completion of IDT’s retrospective review. The identified FCOI must be reported to the relevant PHS Awarding Component in accordance with this Policy.

2. Retrospective Review for Bias.

There may be times when an FCOI is not identified or managed in a timely manner, including: failure by the Investigator to disclose a Significant Financial Interest that is determined by IDT to constitute an FCOI; failure by IDT to review or manage such an FCOI; or failure by the Investigator to comply with an FCOI management plan. In the event such noncompliance is identified, IDT will, within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator’s activities and the research to determine whether there was any bias in the design, conduct or reporting of the research or any portion thereof during the time period of the noncompliance. Any FCOI report submitted with respect to such research will be updated as necessary in light of the results of the retrospective review.

3. Documentation of Retrospective Review.

IDT will document the following with regard to any retrospective review:

a) Project number.
b) Project title.
c) Project director (PD)/principal investigator (PI) or contact PD/PI if a multiple PD/PI model is used.
d) Name of the Investigator with the FCOI.
e) Name of the entity with which the Investigator has the FCOI.
f) Reason(s) for the retrospective review.
g) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed).
h) Findings of the review.
i) Conclusions of the review.

4. Notification of Awarding Agency; Mitigation Report.

If bias is found in the design, conduct or reporting of PHS-funded research during the period of noncompliance, IDT will promptly notify the relevant PHS Awarding Component and will submit a mitigation report, which will include at least the elements documented in the retrospective review and a description of the impact of the bias on the research project IDT’s plan of action or actions taken to eliminate or mitigate the effect of the bias.

E. IDT Notification and Reporting to PHS Awarding Agencies

1. PHS Notification.

For PHS-funded research, IDT will provide all required notifications and reports to the relevant PHS Awarding Component, in accordance with applicable regulations and this Policy.1


2. FCOI Reports.

a) Types of FCOI Reports.
IDT will report any identified FCOI that is related to PHS-funded research to the relevant PHS awarding agency, whether identified in advance of commencing a PHS-funded research project (an “Initial FCOI Report”) or in the course of an on-going PHS-funded research project as a result of new FCOI information (“Updated FCOI Report”). For any identified FCOI related to on-going PHS-funded research that was previously reported in an Initial FCOI Report, IDT will provide an annual FCOI report that addresses the status of the FCOI (including any changes in the value of the previously reported interest) and any changes to the management plan (“Annual FCOI Report”). Such Annual FCOI Reports will be provided for the duration of the PHS-funded research.

b) Timing of FCOI Reports.
IDT will provide required FCOI reports in accordance with the following timeframes:

(i) Initial FCOI Reports: prior to the expenditure of any funds.
(ii) Updated FCOI Reports: within sixty (60) days of identification of a new FCOI (whether due to a new Investigator or a new FCOI disclosed by an existing Investigator) or identification of an FCOI that was not timely disclosed or managed.
(iii) Annual FCOI Reports: at least annually, in accordance with the awarding agency’s specifications. For NIH-funded research, the Annual FCOI Report is due at the same time as IDT is required to submit the annual progress report for a grant, including a multi­year funded progress report if applicable, or at the time of the extension.

c) Content of FCOI Reports.
Any FCOI Report shall provide sufficient information to enable the PHS awarding agency to understand the nature and extent of the FCOI and to assess the appropriateness of IDT’s management plan. Any FCOI Report will include at least the following information:

(i) Project number.
(ii) Project Director/Principal Investigator (“PD/PI”) or contact PD/PI if a multiple-PD/PI model is used.
(iii) Name of the Investigator with the FCOI.
(iv) Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium).
(v) Value of the financial interest, provided in dollar ranges, or a statement that the interest is one whose value cannot be readily determined through reference to pubic prices or other reasonable measures of fair market value.
(vi) A description of how the financial interest relates to the PHS-funded research and the basis for IDT’s determination that the financial interest conflicts with such research.
(vii) A description of the key elements of IDT’s management plan, including: the role and principal duties of the conflicted Investigator in the research; the conditions of the management plan; how the management plan is designed to safeguard objectivity in the research; confirmation of the Investigator’s agreement to the management plan; how the management plan will be monitored to ensure Investigator compliance; and any other information IDT deems necessary to meet its obligations under applicable regulations and this Policy.

d) Additional Notifications.
In addition to the required FCOI reports, IDT will promptly notify the relevant PHS Awarding Component in the event that it finds that an Investigator’s failure to comply with this Policy or an imposed management plan has biased the design, conduct, or reporting of PHS-funded research (such notification will include the corrective action taken or to be taken in response to the identified Investigator non-compliance).

F. Requirements for Subrecipients of PHS-Funded Research

If IDT carries out the PHS-funded research through a subrecipient (e.g., subcontractors, or consortium members), IDT (the awardee Institution) must take reasonable steps to ensure that any subrecipient Investigator complies with this part by:
1) Incorporating as part of a written agreement with the subrecipient terms that establish whether IDT’s FCOI Policy or the subrecipient’s FCOI policy will apply to the subrecipient’s Investigators.

a) If the subrecipient’s Investigators must comply with the subrecipient’s FCOI policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with 45 C.F.R. Part 94. If the subrecipient cannot provide this certification, the subrecipient’s Investigators will be subject to the requirements of this Policy for disclosing Significant Financial Interests that are directly related to the subrecipient’s work for IDT.

b) Additionally, if the subrecipient’s Investigators must comply with the subrecipient’s FCOI policy, the agreement with the subrecipient shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to IDT. Such time period(s) shall be sufficient to enable IDT to comply with this Policy and to provide timely FCOI reports, as necessary, to the PHS or the PHS Awarding Component.

c) Alternatively, if the subrecipient’s Investigators must comply with IDT’s FCOI Policy, the agreement with the subrecipient shall specify time period(s) for the subrecipient to submit all Investigator disclosures of Significant Financial Interests to IDT. Such time period(s) shall be sufficient to enable IDT to comply timely with its review, management, and reporting obligations as set forth in this Policy and in 45 C.F.R. Part 94.

2) Providing timely FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators (i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI).

V. Notice and Training

A) Notice.
IDT shall provide all Investigators with notice of this Policy, the Investigator’s responsibilities regarding disclosure of Significant Financial Interests and of the regulations in 45 C.F.R. Part 94.
B) Training Requirement.
All Investigators must receive training on this Policy prior to engaging in Research related to any PHS-funded contract.
C) Training Frequency. Investigators must complete training at least every four years following the initial training. In addition, Investigators must receive training immediately in any of the following circumstances:
1. IDT revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;
2. An Investigator is new to IDT; or
3. IDT finds that an Investigator is not in compliance with this Policy or a management plan.

VI. Non-Compliance and Disciplinary Action

A) Compliance Expectation
Individuals subject to this Policy are expected and required to comply fully and promptly with the requirements of this Policy.
B) Disciplinary Action
Investigators who deliberately or repeatedly fail to fully and truthfully disclose Significant Financial Interests, or fail to comply with any Management Plan, shall be subject to disciplinary action, up to and including termination.

VII. Public Access

Prior to expenditure of any funds under a PHS-funded research project, IDT will ensure public access, via IDT’s publicly accessible website , to this Policy. Prior to expenditure of any funds under a PHS-funded research project, IDT will ensure public access, via IDT’s publicly accessible website or written response to any requestor within five (5) business days of a request, to the following information concerning any FCOI involving Key Personnel that is still held by Key Personnel:
The Investigator’s name;
The Investigator’s title and role with respect to the research project;
The name of the entity in which the Significant Financial Interest is held;
The nature of the Significant Financial Interest that forms the basis of the FCOI
The approximate dollar value of the significant financial interest provided in dollar ranges, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

VIII. Record Retention

IDT will maintain records relating to all Investigator disclosures of financial interests and IDT’s review of, and response to, such disclosures (whether or not a disclosure resulted in a determination of an FCOI), and all actions under this Policy or retrospective review, if applicable, for at least three years from the date of final payment by PHS.
RESPONSIBILITY FOR MAINTENANCE OF THIS POLICY: Director Global Treasury
RESPONSIBILITY FOR OVERSIGHT AND REVIEW: Director Global Treasury
REVIEW AND APPROVAL DATE: June 02, 2017
APPROVED BY: Andreas Kastenbauer, Dr. Christian Wirth, Chief Executive Officers
1To the extent that a U.S. government contract requires notice to be provided to the Contracting Officer assigned to the contract, then notice shall be provided to both the assigned Contracting Officer and the PHS
Awarding Component. Such notification requirement, where applicable, relates to all notification and reporting obligations addressed in this Policy.